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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (sALCL)
Structure of brentuximab vedotin
Brentuximab vedotin on track for BLA filing with FDA during first half of 2011. [© Sebastian Kaulitzki – Fotolia.com]
Brentuximab is a human antibody. The antibody portion of Brentuximab vedotin has the sequence of two copies of:
>Brentuximab vedotin - heavy chain QIQLQQSGPEVVKPGASVKISCKASGYTFTDYYITWVKQKPGQGLEWIGWIYPGSGNTKY NEKFKGKATLTVDTSSSTAFMQLSSLTSEDTAVYFCANYGNYWFAYWGQGTQVTVSAAST KGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLY SLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTY RVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTK NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG NVFSCSVMHEALHNHYTQKSLSLSPG >Brentuximab vedotin - light chain DIVLTQSPASLAVSLGQRATISCKASQSVDFDGDSYMNWYQQKPGQPPKVLIYAASNLES GIPARFSGSGSGTDFTLNIHPVEEEDAATYYCQQSNEDPWTFGGGTKLEIKRTVAAPSVF IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
February 01, 2013
Seattle Genetics, Inc. today announced that Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.
“they are focused on making ADCETRIS available globally to all eligible patients with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the recent approval in the European Union, are important milestones to accomplish this goal,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Now that Health Canada has approved ADCETRIS, we are committed to working closely with public and private insurers to secure reimbursement coverage for patients in Canada.”
“The approval of ADCETRIS in Canada marks a significant milestone for patients with relapsed HL or sALCL who have had few new treatment options in several decades,” Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.
Health Canada grants NOC/c, a form of market approval, on the basis of promising evidence of clinical effectiveness, for products intended for the treatment of serious, life-threatening or severely debilitating illnesses that meet a serious unmet medical need or demonstrate a significant improvement in the benefit/risk profile over existing therapies. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the anticipated clinical benefit of ADCETRIS in these patients. Two confirmatory phase III clinical trials evaluating ADCETRIS in the front-line treatment setting of HL and mature T-cell lymphoma (MTCL), including sALCL, are currently underway and enrolling patients.
ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients. ADCETRIS is administered in hospitals through IV infusion over 30 minutes every three weeks and patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately one year).
ADCETRIS is the first in a new class of antibody-drug conjugates (ADCs) to be approved in Canada. Using Seattle Genetics’ proprietary technology, the ADC consists of a monoclonal antibody directed to an antigen called CD30. The monoclonal antibody is connected to a cell-killing agent by a linker system that is designed to be stable in the bloodstream but to release the cell-killing agent into CD30-expressing cells, resulting in target cell death. The CD30 antigen is known to be expressed on the Reed-Sternberg cells of HL and on sALCL, an aggressive type of T-cell non-Hodgkin lymphoma.
“Health Canada’s approval of ADCETRIS is the first step in getting patients access to this important therapy,” said Sue Robson, Executive Director of Lymphoma Foundation Canada. “The Lymphoma Foundation is committed to working with Canada provincial governments to ensure that appropriate patients have access to this new therapy.”
About Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.
Brentuximab vedotin (INN, codenamed SGN-35 and previously cAC10-vcMMAE) is an antibody-drug conjugate approved to treat anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma. The U.S. Food and Drug Administration granted the agent an accelerated approval on August 19, 2011 for use against these two diseases.[1] It is marketed as Adcetris.[2]
The compound consists of the chimeric monoclonal antibody brentuximab (which targets the cell-membrane protein CD30) linked to three to five units of the antimitotic agent monomethyl auristatin E (MMAE, reflected by the ‘vedotin’ in the drug’s name). The antibody portion of the drug attaches to CD30 on the surface of malignant cells, delivering MMAE which is responsible for the anti-tumour activity.[3][4] Hence it is an antibody-drug conjugate.
In a 2010 clinical trial,[5] 34% of patients with refractory Hodgkin Lymphoma achieved complete remission and another 40% had partial remission.[6] Tumor reductions were achieved in 94% of patients. In ALCL, 87% of patients had tumors shrink at least 50% and 97% of patients had some tumors shrinkage.[7]
On 28 February 2011 a Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for the use of brentuximab vedotin in relapsed or refractory Hodgkin’s lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma.[8] Both indications were approved by the FDA in Aug 2011.[9]
For these same indications brentuximab vedotin received a conditional Marketing authorization from the European Medicines Agency in october 2012.[10]
- FDA: Brentuximab Vedotin
- Seattle Genetics to Present Brentuximab Vedotin and SGN-75 Clinical Data at the American Society of Clinical Oncology Annual Meeting
- Seattle Genetics: Brentuximab vedotin (SGN-35)
- Francisco, Joseph A; et al. (2003). “cAC10-vcMMAE, an anti-CD30–monomethyl auristatin E conjugate with potent and selective antitumor activity”. Blood 102 (4): 1458–1465. doi:10.1182/blood-2003-01-0039. PMID 12714494.
- ClinicalTrials.gov NCT00848926 A Pivotal Open-Label Trial of SGN-35 for Hodgkin Lymphoma
- “Seattle Genetics and Millennium Report Positive Data from Pivotal Trial of Brentuximab Vedotin (SGN-35) in Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting”. Dec 2010.
- “Is Seattle Genetics the Next Big Thing?”. 2 Dec 2010.
- “Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL”. 28 Feb 2011.
- Genetic Engineering & Biotechnology News: Seattle Genetics’ Antibody-Drug Conjugate Receives FDA Okay to Treat Lymphomas
- http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002455/WC500135004.pdf
FDA Approves Ravicti (glycerol phenylbutyrate)for the Chronic Management of Some Urea Cycle Disorders
FDA Approves Ravicti (glycerol phenylbutyrate)for the Chronic Management of Some Urea Cycle Disorders
Ravicti is marketed by Hyperion Therapeutics, based in South San Francisco, Calif.
February 1, 2013 — The U.S. Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.
UCDs are genetic disorders that involve deficiencies of specific enzymes involved in the urea cycle, a series of biochemical steps normally required to remove ammonia from the blood. When protein is absorbed and broken down by the body, it produces nitrogen as a waste product. The urea cycle removes nitrogen from the blood and converts it to urea, which is removed from the body through urine. In people with UCDs, nitrogen accumulates and remains in the body as ammonia, which can travel to the brain and cause brain damage, coma or death.
Ravicti, a liquid taken three times a day with meals, helps dispose of ammonia in the body. It is intended for patients whose UCD cannot be managed by a protein-restricted diet or amino acid supplements alone. Ravicti must be used with a protein-restricted diet and, in some cases, dietary supplements.
“Ravicti provides another treatment for chronic management of urea cycle disorders, a group of life-threatening conditions,” said Donna Griebel, M.D., director of the Division of Gastrointestinal and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “The approval of this new therapeutic option demonstrates FDA’s commitment to providing treatments for patients suffering from rare diseases.”
Ravicti was reviewed under the agency’s fast track program, designed to facilitate the development and expedite the review of drugs to treat serious diseases, fill unmet medical needs, and get important new drugs to patients earlier. Ravicti also was granted orphan product designation because it is intended to treat a rare disease.
Glycerol phenylbutyrate (HPN-100) is a pro-drug of phenylbutryrate and a pre-pro-drug of phenylacetic acid (PAA), the active moiety of Buphenyl, the only therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders — carbamylphosphate synthetase, ornithine transcarbamylase, and argininosuccinic acid synthetase. HPN-100, which is dosed orally in liquid form, provides an alternative pathway to the urea cycle for the disposal of waste nitrogen through the renal excretion of phenylacetylglutamine, which is formed from PAA and glutamine.
伯舒替尼 Bosutinib
Bosutinib Monohydrate (伯舒替尼)
(Bosulif®)
Approved sept4 2012 by FDA
PMDA SEPT26 2014
EMA MAR 27 2013
A kinase inhibitor indicated for the treatment of adult patients with Ph+ chronic myelogenous leukemia (CML).
WYETH INNOVATOR
PFIZER DEVELOPER
SKI-606; SK-606
CAS No.380843-75-4 (Free form)
CAS 918639-08-4(Bosutinib Monohydrate)
Bosutinib (rINN/USAN; codenamed SKI-606, marketed under the trade name Bosulif) is atyrosine kinase inhibitor undergoing research for use in the treatment of cancer. [1] [2]Originally synthesized by Wyeth, it is being developed by Pfizer.
。
Some commercial stocks of bosutinib (from sources other than the Pfizer material used for clinical trials) have recently been found to have the incorrect chemical structure, calling the biological results obtained with them into doubt.[3]
Bosutinib received US FDA approval on September 5, 2012 for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+)chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.[4][5][6]
Article
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on January 17, 2013, adopts a positive opinion, recommending a conditional marketing authhorization for Pfizer’s orphan drug Bosulif (Bosutinib) for Chronic Leukemia (CML). Bosutinib receives orphan designation from the European Commission (EC) on August 4, 2010, for CML.
Pfizer receives FDA approval on September 4, 2012, for orphan drug Bosulif (Bosutinib) for CML. Pfizer receives on February 24, 2009, FDA Orphan Drug Designation (ODD) for Bosutinib for CML.
Per a September 2012 article in FierceBioTech.com, a Pfizer spokesperson says that “the drug will cost less than $8,200/month”/patient in the US. In other words, treatment will cost approximately $98,400/patient/year. Also per FierceBiotech,“Bosulif is the 3rd new medicine from Pfizer Oncology’s pipeline to be approved by the FDA in just 13 months ….”.
ARTICLE
Pfizer’s response to compound fraud spotlights quality issues
read ………http://www.rsc.org/chemistryworld/2015/12/pfizer-bogus-bosutinib-isomer-fraud-leukaemia-drug
Synthesis
Confirmation of Bosutinib Structure; Demonstration of Controls To Ensure Product Quality
Nonbranded/unauthorized vendors had been manufacturing/selling what they described as bosutinib, while the material supplied was actually an isomer of bosutinib. This raised concerns within the worldwide research community around the established control strategies for bosutinib. This manuscript summarizes that the appropriate testing was in place to ensure product quality, along with additional experimentation that was performed to confirm that testing (methods) can differentiate the potential isomeric compounds. Testing includes the use of IR for identity confirmation of raw materials, material characterization by NMR, single crystal X-ray to confirm structure, and evaluation of several potential isomers by HPLC, melting point, and IR, thus demonstrating the control strategy needed to ensure the product controls.
REFERENCES
- Puttini M, Coluccia AM, Boschelli F, Cleris L, Marchesi E, Donella-Deana A, Ahmed S, Redaelli S, Piazza R, Magistroni V, Andreoni F, Scapozza L, Formelli F, Gambacorti-Passerini C. In vitro and in vivo activity of SKI-606, a novel Src-Abl inhibitor, against imatinib-resistant Bcr-Abl+ neoplastic cells. Cancer Res. 2006 Dec 1;66(23):11314-22. Epub 2006 Nov 17.
- Vultur A, Buettner R, Kowolik C, et al. (May 2008). “SKI-606 (bosutinib), a novel Src kinase inhibitor, suppresses migration and invasion of human breast cancer cells”.Mol. Cancer Ther. 7 (5): 1185–94. doi:10.1158/1535-7163.MCT-08-0126.PMC 2794837. PMID 18483306.
- Derek Lowe, In The Pipeline (blog), “Bosutinib: Don’t Believe the Label!”
- Cortes JE, Kantarjian HM, Brümmendorf TH, Kim DW, Turkina AG, Shen ZX, Pasquini R, Khoury HJ, Arkin S, Volkert A, Besson N, Abbas R, Wang J, Leip E, Gambacorti-Passerini C. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood. 2011 Oct 27;118(17):4567-76. Epub 2011 Aug 24.
- Cortes JE, Kim DW, Kantarjian HM, Brümmendorf TH, Dyagil I, Griskevicus L, Malhotra H, Powell C, Gogat K, Countouriotis AM, Gambacorti-Passerini C. Bosutinib Versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: Results From the BELA Trial. J Clin Oncol. 2012 Sep 4. [Epub ahead of print]
- “Bosulif Approved for Previously Treated Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia”. 05 Sep 2012.
-
P Bowles et al, Org. Process Res. Dev., 2015, DOI: 10.1021/acs.oprd.5b00244
8 N M Levinson and S G Boxer, PLoS One, 2012, 7, e29828 (DOI: 10.1371/journal.pone.0029828)
9 N Beeharry et al, Cell Cycle, 2014, 13, 2172 (DOI: 10.4161/cc.29214)
update…………….
file:///C:/Users/Inspiron/Downloads/molecules-15-04261%20(1).pdf
Synthesis of Bosutinib from 3-Methoxy-4-hydroxybenzoic Acid
Jun 11, 2010 – Abstract: This paper reports a novel synthesis of bosutinib starting from … C-NMR, MS and the purities of all the compounds were determined …
4-(2,4-Dichloro-5-methoxyphenylamino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline- 3-carbonitrile (10). A mixture of 7-(3-chloropropoxy)-4-(2,4-dichloro-5-methoxyphenylamino)-6-methoxyquinoline-3-carbonitrile (9, 0.328 g, 0.7 mmol) and sodium iodide (0.11 g, 0.70 mmol) in N-methylpiperazine (4 mL) was heated at 80 ºC for 12 h. The reaction mixture was concentrated in vacuo and partitioned between ethyl acetate and saturated aqueous sodium bicarbonate. The organic layer was washed with brine, dried over sodium sulfate, filtered, and concentrated in vacuo. The residue was purified by column chromatography, eluting with 30% methanol in dichloromethane. The fractions containing product were collected and concentrated in vacuo. Diethyl ether was added to the residue, and the light pink solid was collected by filtration (0.28 g, 75% yield, 98.7% HPLC purity): m.p. 116–120 ºC;
1H-NMR (DMSO-d6): 1.92–1.97 (m, 2H), 2.15 (s, 3H), 2.32–2.46 (m, 10H), 3.84 (s, 3H), 3.93 (s, 3H), 4.19 (t, J = 6.3 Hz, 2H), 7.31 (br s, 2H), 7.43 (s, 1H), 7.64 (s, 1H), 8.52 (s, 1H), 9.51 (s, 1H);
13C-NMR (CDCl3): 25.96, 45.68, 52.67, 52.67, 54.24, 54.72, 54.72, 56.01, 60.71, 66.87, 89.10, 101.66, 101.66, 109.12, 113.95, 117.17, 122.99, 122.99, 128.27, 137.88, 146.15, 148.13, 148.51, 149.50, 150.43, 153.03;
MS (ES) m/z 530.2, 532.2 (M+1).
…………………..
Structural and spectroscopic analysis of the kinase inhibitor …
files.figshare.com/337292/Figure_S2.doc
by NM Levinson – Cited by 39 – Related articles
NMR spectroscopy on bosutinib and the bosutinib isomer. As described in the main text, the 1H NMR spectra of the compounds we purchased from LC Labs and …
Figure S2. NMR experiments on bosutinib and the bosutinib isomer. A) The structure of bosutinib and a putative structure for the bosutinib isomer are shown. The blue numbers on the bosutinib structure represent the five aromatic proton-carbon pairs. The numbers on the aniline ring of the bosutinib isomer are 13C chemical shifts. B) NMR spectra. In the top left panel, 1H-13C HSQC spectra of bosutinib and the bosutinib isomer are shown. The thick black lines connect the peaks that arise from the equivalent proton-carbon pairs in the two compounds. The thin gray lines are intended to guide the eye to the corresponding peaks in the 1-dimensional spectra. The peaks for the five aromatic proton-carbon pairs in authentic bosutinib are indicated with large blue numbers. These putative assignments are based on 13C chemical shift predictions. The bottom panel shows the 1H NMR spectra of both compounds. The peak located at 7.34 ppm in the bosutinib isomer sample, which integrates to 2, is indicated. The colored numbers directly next to the peaks are the peak integrations. The panel on the upper right shows the aromatic region of the 13C NMR spectrum of the bosutinib isomer. The peak located at 123 ppm, which displays an integrated intensity of 2, is indicated.
//////////////Clc1c(OC)cc(c(c1)Cl)Nc4c(C#N)cnc3cc(OCCCN2CCN(CC2)C)c(OC)cc34
Health Canada approves Forest Laboratories Bystolic
Health Canada approves Forest Laboratories Bystolic
The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1′-[(2RS,2’SR)bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2′-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4•HCl) with the following structural formula:
 |
SRRR – or d-nebivolol hydrochloride
RSSS – or l-nebivolol hydrochloride
MW: 441.90 g/mol
Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene.
BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.
Class: beta-Adrenergic Blocking Agents
Chemical Name: (1RS,1′RS)-1,1′-[(2RS,2′SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2′-iminodiethanol hydrochloride
Molecular Formula: C22H25F2NO4•HCl
CAS Number: 152520-56-4
Brands: Bystolic
Health Canada has issued a notice of compliance for Forest Laboratories Canada’s hypertension therapy, Bystolic (nebivolol) tablets.
The company anticipates making the hypertension medication, that is to be administered once a day, available to patients across Canada in the second quarter of 2013.
Forest Laboratories corporate development and strategic planning senior vice president David Solomon said, “We are pleased that Health Canada has granted approval for BYSTOLIC. This is an important milestone for Forest, as it is the first product approved for our newly established Canadian subsidiary.”
Nebivolol is a beta adrenergic receptor blocking agent which is metabolized by various routes such as glucuronidation and hydroxylation by CYP2D6.
Possible factors that allow Bystolic to act as antihypertensive agent include decreased heart rate, decreased myocardial contractility, diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, suppression of renin activity and vasodilation and decreased peripheral vascular resistance.
Jetrea(TM) receives positive CHMP opinion
Jetrea(TM) receives positive CHMP opinion
Ocriplasmin is a recombinant truncated form of human plasmin with a molecular weight of 27.2 kD a produced by recombinant DNA technology in a Pichia pastoris expression system.
JETREA is a sterile, clear and colorless solution with no preservatives in a single-use glass vial containing 0.5 mg ocriplasmin in 0.2 mL solution for intravitreal injection after dilution.
Each vial contains 0.5 mg ocriplasmin (active) and 0.21 mg citric acid, 0.75 mg mannitol, sodium hydroxide (for pH adjustment) and water for injection. The pH of the solution is 3.1.
Jetrea(TM) (ocriplasmin),
USFDA Approves Octaplas
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336009.htm
FRI 18 JAN
Octaplas is presented as a solution for infusion containing 45 – 70 mg/mL human plasmaproteins.
Biogen Idec and Elan have filed for approval for Tysabri (Natalizumab) as first-line treatment for relapsing forms of MS in anti-JC virus (JCV) antibody negative patients
Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is used in the treatment of multiple sclerosis and Crohn’s disease. It is co-marketed by Biogen Idec and Élan as Tysabri, and was previously namedAntegren. Natalizumab is administered by intravenous infusion every 28 days. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab has proven effective in treating the symptoms of both diseases, preventing relapse, vision loss, cognitive decline and significantly improving quality of life in people with multiple sclerosis, as well as increasing rates of remission and preventing relapse in Crohn’s disease.
Natalizumab was approved in 2004 by the U.S. Food and Drug Administration (FDA). It was subsequently withdrawn from the market by its manufacturer after it was linked with three cases of the rare neurological condition progressive multifocal leukoencephalopathy(PML) when administered in combination with interferon beta-1a, anotherimmunosuppressive drug often used in the treatment of multiple sclerosis. After a review of safety information and no further deaths, the drug was returned to the US market in 2006 under a special prescription program. As of June 2009, ten cases of PML were known. However, twenty-four cases of PML had been reported since its reintroduction by October 2009, showing a sharp rise in the number of fatalities and prompting a review of the chemical for human use by the European Medicines Agency.[1][2][3] By January 2010, 31 cases of PML were attributed to natalizumab.[4] The FDA did not withdraw the drug from the market because its clinical benefits outweigh the risks involved.[5] In the European Union, it has been approved for human use only for the treatment of multiple sclerosis and only then as a monotherapy because the initial cases of PML, and later the fatalities, were said by the manufacturers to be linked to the use of previous medicines by the patients.
Biogen Idec announced the initiation of the first clinical trial of natalizumab as a potential cancer treatment as of September 5, 2008.[6]
- Meeting highlights from the Committee for Medicinal Products for Human Use” (pdf). European Medicines Agency. 2009-10-22. Retrieved 2010-08-31.
- Hirschler, B; Cowell D (2009-10-29). “EU agency reports 24th case of Tysabri infection”. Reuters. Retrieved 2010-08-31.
- Clarke T; Orlofsky S; Von Ahn L (2009-06-29). “Biogen reports 10th case of PML brain infection”. Reuters. Retrieved 2010-08-31.
- Jeffrey, S (2010-02-05). “PML Risk Increases With Repeated Natalizumab Infusions: FDA”. Medscape. Retrieved 2010-08-31.
- Hitti, M (2008-08-01). “MS Drug Tysabri Tied to Brain Infection”. WebMD. Retrieved 2010-08-31.
- “Biogen Idec testing Tysabri as a cancer treatment”. The Boston Globe. 2008-09-05. Retrieved 2008-09-05.
FDA approves first flu vaccine made using insect virus
FDA approves first flu vaccine made using insect virus
17 January 2013
The US Food and Drug Administration has approved the world’s first influenza vaccine manufactured using an insect virus.
Flublok, manufactured by Protein Sciences, is produced using a ‘baculovirus expression system’ that does not require the virus to be grown in chicken eggs, as is usually the case.
This means the vaccine can be made quickly in the event of a pandemic and without any of the infectious risk traditionally associated with vaccine manufacture.
Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, explained, “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”
Flublok has three times the amount of hemagglutinin (HA) – the active ingredient in all inactivated influenza vaccines – to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.
The vaccine is produced by insect cells which are infected by the baculovirus combined with the hemagglutinin gene. The cells are then grown in culture to churn out the protein.
Protein Sciences CEO Manon Cox said, “We use advanced scientific technology to make just the active ingredient of the vaccine without any other viral components. This is the first influenza vaccine on the market to do so.”
The FDA approved Flublok for immunization in adults aged 18 to 49 after it was proved to be 44.6% effective against all circulating influenza virus during a study involving 2,300 people in the US.
The vaccine was indicated as safe to use during a separate study of 2,500 people.
Adverse events included pain at the site of injection, headache, fatigue and muscle aches, events also typical for conventional egg-based, inactivated influenza vaccines.
BOTOX® (onabotulinumtoxinA) Receives U.S. Food and Drug Administration Approval for the Treatment of Overactive Bladder for Adults Who Have an Inadequate Response to or Are Intolerant of an Anticholinergic Medication
BOTOX® (onabotulinumtoxinA) Receives U.S. Food and Drug Administration Approval for the Treatment of Overactive Bladder for Adults Who Have an Inadequate Response to or Are Intolerant of an Anticholinergic Medication
Allergan, Inc. (NYSE:AGN) announced today that the U.S. Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication. In two double-blind, randomized, multi-center, placebo-controlled 24-week clinical trials among adults with overactive bladder who had not been adequately managed with anticholinergic treatments, BOTOX® reduced daily urinary incontinence (leakage) episodes as compared to placebo by 50 percent or more by week 12 (reduction of 2.5 episodes from baseline of 5.5 episodes in one study and reduction of 3 episodes from baseline of 5.5 episodes in the second study for those treated with BOTOX® vs. a reduction of 0.9 episodes from a baseline of 5.1 episodes in one study and a reduction of 1.1 episodes from a baseline of 5.7 episodes in the second study for those treated with placebo).1
Allergan has a long-standing commitment to study the potential of BOTOX® to treat a number of different medical conditions
“Allergan has a long-standing commitment to study the potential of BOTOX® to treat a number of different medical conditions,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development, Chief Scientific Officer. “With today’s approval, BOTOX® is now approved for 26 different indications in more than 85 countries. Most importantly, today’s FDA approval is a milestone in the treatment of this burdensome condition and will provide a novel option for urologists and their OAB patients.”
While the exact cause is often unknown, OAB is a medical condition that results in an uncontrolled urge to urinate, frequent urination and, in many patients, uncontrollable leakage of urine. In the United States, an estimated 14.7 million adults experience symptoms of OAB with urinary incontinence (unexpected leakage of urine).2 Anticholinergics, which are often prescribed as pills, are used by approximately 3.3 million Americans with OAB, with or without urinary incontinence, to manage their condition.3 It is estimated, however, that greater than 50 percent of these patients stop taking at least one oral medication within 12 months, likely due to an inadequate response to, or intolerance of, the medication.4
“Overactive bladder can be a difficult condition to treat as there have been limited options for patients when currently available medications have failed to provide them with adequate relief,” said Dr. Victor Nitti*, Vice Chairman, Department of Urology and Director of Female Pelvic Medicine and Reconstructive Surgery at NYU Langone Medical Center. “With the approval of BOTOX®, we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to six months.”
The median duration for efficacy with BOTOX® at reducing urinary leakage and other symptoms of OAB in the two clinical studies was 135-168 days compared to 88-92 days with placebo based on qualification for retreatment. To qualify for retreatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least two urinary incontinence episodes over three days. BOTOX® treatment relieves OAB symptoms by temporarily calming muscle contractions by blocking the transmission of nerve impulses to the bladder muscle.
BOTOX Cosmetic (onabotulinum toxin A) For Injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution bydialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
The primary release procedure for BOTOX Cosmetic uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols, Units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX Cosmetic is approximately 20 Units/nanogram of neurotoxin protein complex.
Each vial of BOTOX Cosmetic contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; or 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
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Kisumu – Wikipedia, the free encyclopedia
Kisumu is a port city in Kisumu County, Kenya 1,131 m (3,711 ft), with a population of 409,928 (2009 census). It is the third largest city in Kenya, the principal city …
Kisumu CountyKisumu County is one of the new devolved counties of Kenya. Its …
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Kisumu International AirportKisumu International Airport is an airport in Kisumu, Kenya (IATA …
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Boat riding in Kisumu
Local inhabitants near Kisumu, 1911
Clockwise: Lake Victoria Panorama, Kisumu Panorama, sunset at Oginga Odinga street, Downtown, Kiboko Point, Nighttime in Kisumu and Jomo Kenyatta Stadium.
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 Kisumu
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Coordinates:  0°6′S 34°45′E |
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| Country |  Kenya |
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| County | Kisumu County |
Kisumu panorama, viewed from Lake Victoria
Jomo Kenyatta Stadium
Kisumu Harbour. The green vegetation is water hyacinth
Nairobi University Kisumu Campus
DR ANTHONY MELVIN CRASTO Ph.D
Teijin Pharma to launch Ipsen’s Somatuline® subcutaneous injection in the treatment of acromegaly and pituitary gigantism in Japan
Lanreotide
Thursday, 17 January 2013
Teijin Pharma to launch Ipsen’s Somatuline® subcutaneous injection in the treatment of acromegaly and pituitary gigantism in Japan
Somatuline is a synthetic somatostatin analog developed by Ipsen approved in more than 60 countries worldwide. In Japan, Somatuline is available in a differentiated and enhanced presentation with a pre-filled syringe that does not need reconstitution and with a retractable needle that enhances safety for caregivers; Somatuline’s long-lasting effects enable one administration every four weeks.
Somatuline, used in more than 60 countries worldwide, is highly regarded by the medical profession and patients for its long-lasting effects and user-friendly dosing devices. We are pleased to launch Somatuline in Japan, confident that it will offer patients a beneficial treatment option to control the symptoms of acromegaly, or pituitary gigantism, for improved quality of life.
Lanreotide is a man-made protein that is similar to a hormone in the body called somatostatin. Lanreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.
Lanreotide is used to as a long-term treatment in people with acromegaly who cannot be treated with surgery or radiation.
Lanreotide is sometimes given when surgery or radiation treatments have been tried without successful treatment of symptoms.
Lanreotide may also be used for other purposes not listed in this medication guide.
Lanreotide (INN) is a medication used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably carcinoid syndrome. It is a long-actinganalogue of somatostatin, like octreotide.
Lanreotide (as lanreotide acetate) is manufactured by Ipsen, and marketed under the trade name Somatuline. It is available in several countries, including the United Kingdom,Australia and Canada, and was approved for sale in the United States by the Food and Drug Administration (FDA) on August 30, 2007.[2]
- (French) “Lanreotide Acetate”. BIAM. March 5, 2001. Retrieved 2007-03-02.
- “FDA Approves New Drug to Treat Rare Disease, Acromegaly” (Press release). U.S. Food and Drug Administration. August 30, 2007. Retrieved 2007-09-06.
- Rens-Domiano S, Reisine T (1992). “Biochemical and functional properties of somatostatin receptors”. J Neurochem 58 (6): 1987–96.doi:10.1111/j.1471-4159.1992.tb10938.x. PMID 1315373.
- “Somatuline LA”. electronic Medicines Compendium. September 17, 2003. Retrieved 2007-03-02.
- Kvols L, Woltering E (2006). “Role of somatostatin analogs in the clinical management of non-neuroendocrine solid tumors”.Anticancer Drugs 17 (6): 601–8. doi:10.1097/01.cad.0000210335.95828.ed. PMID 16917205.
- Susini C, Buscail L (2006). “Rationale for the use of somatostatin analogs as antitumor agents”. Ann Oncol 17 (12): 1733–42.doi:10.1093/annonc/mdl105. PMID 16801334.
- “Somatuline Autogel”. electronic Medicines Compendium. April 12, 2007. Retrieved 2007-04-19.
- Valéry C, Paternostre M, Robert B, Gulik-Krzywicki T, Narayanan T, Dedieu J-C, Keller G, Torres M-L, Cherif-Cheikh R, Calvo P, and Artzner F (2003). “Biomimetic organization: Octapeptide self-assembly into nanotubes of viral capsid-like dimension”. Proceedings of the National Academy of Sciences of America 100 (18): 10258–62. doi:10.1073/pnas.1730609100.
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Additional Somatuline Depot Information
- Somatuline Depot Side Effects Center
- Somatuline Depot FDA Approved Prescribing Information including Dosage
- DR ANTHONY MELVIN CRASTO Ph.D
MOBILE-+91 9323115463GLENMARK SCIENTIST , NAVIMUMBAI, INDIA
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