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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Sanofi Pasteur has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending market approval for Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine).
FEB22,2013
French drug major Sanofi’s vaccines subsidiary Sanofi Pasteur has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending market approval for Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine).
Hexyon/Hexacima is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
The new vaccine will be commercialized under the brand name Hexyon in Western European countries by Sanofi Pasteur MSD, the joint venture between US pharma giant Merck & Co and Sanofi Pasteur, and under the brand name Hexacima in Eastern European countries by Sanofi Pasteur.
“Availability of Hexyon/Hexacima ready-to-use, 6-in-1 pediatric vaccine will raise the standard of care of vaccination for millions of children. It reduces the number of vaccination visits for infants and it is more convenient for parents to complete the recommended vaccination schedule and thus better protect their children against six major childhood diseases,” said Olivier Charmeil, president and chief executive of Sanofi Pasteur, adding: “Upon licensure, we intend to introduce Hexyon/Hexacima vaccine in countries that are looking for improved and effective solutions for public immunization programs.”
Key benefits of Hexyon/Hexacima vaccine
According to Sanofi, the key benefits of Hexyon/Hexacima include the following:
• Hexyon/Hexacima is a fully liquid, ready-to-use vaccine; no reconstitution is needed prior to administration, which improves convenience for health care professionals. It is available in vial and pre-filled syringe presentations;
• by combining six vaccines into one, the vaccine reduces the number of injections, which improves comfort and vaccination compliance for infants, and
• the use of acP (acellular pertussis) antigens and IPV (inactivated poliovirus vaccine) improves safety and reduces reactogenicity as compared to wcP (whole cell pertussis)-containing vaccines and OPV (oral polio vaccine).
Assuming licensure, Hexyon/Hexacima would be indicated for primary and booster vaccination of infants from six weeks of age in accordance with official recommendations. The CHMP positive opinion is supported by results of multi-center clinical studies involving around 5,000 infants. Phase III clinical studies comparing Hexyon/Hexacima to licensed combination vaccines demonstrated that the vaccine is safe and induces a robust immune response against all six targeted diseases.
Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem (gadoterate meglumine)
| Cas No. | 98059-18-8 |
| Name | 2-[4,7-bis(carboxylatomethyl)-10-(carboxymethyl)-1,4,7, 10-tetrazacyclododec-1-yl]acetate; gadolinium(3+); (2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol |
Dotarem (gadoterate meglumine)
Company: Guerbet
Treatment for: Diagnostic
Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent under review for use in magnetic resonance imaging (MRI).
VILLEPINTE, France, Feb. 14, 2013 Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.
Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.
Gadoteric acid
Gadoteric acid (trade names Artirem, Dotarem) is a macrocycle-structured gadolinium-based MRI contrast agent. It consists of the organic acid DOTA as a chelating agent, and gadolinium (Gd3+), and is used in form of the meglumine salt.[1] The drug is approved and used in a number of countries worldwide.[2]
References
- Herborn, C. U.; Honold, E.; Wolf, M.; Kemper, J.; Kinner, S.; Adam, G.; Barkhausen, J. (2007). “Clinical Safety and Diagnostic Value of the Gadolinium Chelate Gadoterate Meglumine (Gd-DOTA)”. Investigative Radiology 42 (1): 58–62. doi:10.1097/01.rli.0000248893.01067.e5. PMID 17213750. edit
- Drugs.com: Gadoteric Acid
A gadolinium chelate paramagnetic contrast agent. When placed in a magnetic field, gadoterate meglumine produces a large magnetic moment and so a large local magnetic field, which can enhance the relaxation rate of nearby protons; as a result, the signal intensity of tissue images observed with magnetic resonance imaging (MRI) may be enhanced. Because this agent is preferentially taken up by normal functioning hepatocytes, normal hepatic tissue is enhanced with MRI while tumor tissue is unenhanced. In addition, because gadobenate dimeglumine is excreted in the bile, it may be used to visualize the biliary system using MRI.
FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
Bevacizumab, CAS NO 216974-75-3
A MONOCLONAL ANTIBODY
January 23, 2013
Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Avastin has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
On January 23, 2013, the FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy after their cancer worsens (second-line treatment).
People who start on Avastin for mCRC can now stay on Avastin after their cancer worsens.
Bevacizumab (trade name Avastin, Genentech/Roche) is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels. It is licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A).[1] VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States.[citation needed]
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certain metastatic cancers. It received its first approval in 2004, for combination use with standard chemotherapy for metastatic colon cancer.[2] It has since been approved for use in certain lung cancers, renal cancers, and glioblastoma multiforme of the brain.
At one point bevacizumab was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011.[3][4]
- Los, M.; Roodhart, J. M. L.; Voest, E. E. (2007). “Target Practice: Lessons from Phase III Trials with Bevacizumab and Vatalanib in the Treatment of Advanced Colorectal Cancer”. The Oncologist 12 (4): 443–50. doi:10.1634/theoncologist.12-4-443. PMID 17470687.
- http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf
- Pollack, Andrew (18 November 2011). “F.D.A. Revokes Approval of Avastin for Breast Cancer”. New York Times.
- “Cancer drug Avastin loses US approval”. BBC. November 18, 2011.
SEQUENCE
>1bj1_H|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||VH-CH1 (VH(1-123)+CH1(124-215))|||||||231||||MW 24867.8|MW 24867.8| EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT >1bj1_L|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||L-KAPPA (V-KAPPA(1-107)+C-KAPPA(108-213))|||||||214||||MW 23451.0|MW 23451.0| DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >1bj1_J|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||L-KAPPA (V-KAPPA(1-107)+C-KAPPA(108-213))|||||||214||||MW 23451.0|MW 23451.0| DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >1bj1_K|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||VH-CH1 (VH(1-123)+CH1(124-215))|||||||231||||MW 24867.8|MW 24867.8| EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT
FDA approves Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
Structure of trastuzumab emtansine. An ADC is a three-block “engine” — antibody-linker-drug — and each part of the composite molecule has to be carefully selected and assembled. Considered as an armed-antibody, an ADC is a bi-dentate construction where both parts (antibody and drug) of the molecule combine their effect to ensure selectivity and potency. The role of the linker arm is of paramount importance demanding a fine tuning to execute the controlled release and delivery of the two active components in the tumor environment.
Feb. 22, 2013
FDA approves new treatment for late-stage breast cancer
The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.
Kadcyla is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy, and taxanes, a class of chemotherapy drugs commonly used for the treatment of breast cancer.
“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein.”
Referred to as T-DM1 during clinical research, Kadcyla was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Other FDA-approved drugs used to treat HER2-positive breast cancer include trastuzumab (1998), lapatinib (2007) and pertuzumab (2012).
Kadcyla, trastuzumab and pertuzumab are marketed by South San Francisco, Calif.-based Genentech, a member of the Roche Group. Lapatinib is marketed by GlaxoSmithKline, based in Research Triangle Park, N.C
ImmunoGen, Inc. a biotechnology company that develops anticancer therapeutics using its TAP technology, today announced that Roche has reported that the U.S. Food and Drug Administration (FDA) has granted marketing approval to Kadcyla for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy.
“This is a big day for the patients with this cancer and for ImmunoGen,” commented Daniel Junius, President and CEO. “In clinical testing, the findings with Kadcyla in this patient population have been impressive, and we’re delighted the product can now be used by practicing oncologists across the US. In addition to its importance from a medical perspective, commercialization of Kadcyla also marks the start of ImmunoGen earning royalty income.”
Mr. Junius continued, “The efficacy and tolerability seen with Kadcyla underscores the transformative potential of our technology. Kadcyla is the most advanced of ten compounds with our TAP technology already in the clinic, with more in earlier stages of development. We are hopeful that in the future many different types of cancers will be routinely treated with TAP compounds.”
Genentech licensed from ImmunoGen exclusive rights to use the Company’s maytansinoid TAP technology to develop anticancer products targeting HER2.
According to Genentech, Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000. Thus, the cost of the drug is beyond the reach of many women unless they have an insurance plan.
”””””’
Afatinib
-
- Synonyms:BIBW 2992
- ATC:L01XE13
- Use:anticancer; tyrosine kinase inhibitor
- Chemical name:N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide; N-[(3-chloro-4-fluorophenyl)amino]-6-{[4-(N,N-dimethylamino)-1-oxo-2-buten-1-yl]amino}-7-((S)-tetrahydrofuran-3-yloxy)-quinazoline
- Formula:C24H25ClFN5O3
- MW:485.9 g/mol
- CAS-RN:439081-18-2; 850140-72-6
Derivatives
dimaleate
- Formula:C32H33ClFN5O11
- MW:718.1 g/mol
- CAS-RN:850140-73-7
Substance Classes
Synthesis Path
Substances Referenced in Synthesis Path
| CAS-RN | Formula | Chemical Name | CAS Index Name |
|---|---|---|---|
| 446-32-2 | C7H6FNO2 | 4-fluoro-anthranilic acid | |
| 162012-70-6 | C8H3ClFN3O2 | 4-chloro-7-fluoro-6-nitroquinazoline | |
| 367-21-5 | C6H5ClFN | 3-chloro-4-fluoroaniline | |
| 86087-23-2 | C4H8O2 | (S)-(+)-3-hydroxytetrahydrofuran | |
| 314771-76-1 | C18H16ClFN4O2 | N-(3-chloro-4-fluorophenyl)-7-((tetrahydrofuran-3-yl)oxy)quinazoline-4,6-diamine | |
| 13991-36-1 | C4H5BrO2 | bromocrotonic acid | |
| 3095-95-2 | C6H13O5P | diethylphophonoacetic acid | |
| 618061-76-0 | C24H27ClFN4O6P | Diethyl-{[4-((3-chloro-4-fluorophenyl)amino)-7-(((S)-tetrahydro- furan-3-yloxy)quinazolin-6-yl)carbamoyl]-methyl}phosphonate |
|
| 3616-56-6 | C8H19NO2 | (dimethylamino)-acetaldehyde diethylacetate |
Trade Names
| Country | Trade Name | Vendor | Annotation |
|---|---|---|---|
| USA | Gilotrif | Boehringer Ingelheim, 2013 | |
| EU | Giotrif | Boehringer Ingelheim, 2013 |
Formulations
- tabs.; 20, 30 and 40 mg
References
-
- a US 6 251 912 (American Cyanamid; 26.6.2001; appl. 29.7.1998; USA-prior. 1.8.1997).
- WO 0 250 043 (Boehringer Ingelheim; 27.6.2002; appl. 12.12.2001; DE-prior. 20.12.2000).
- US RE 43431 (Boehringer Ingelheim; 29.5.2012; appl. 18.8.2009; DE-prior. 20.12.2000).
- b US 8 426 586 (Boehringer Ingelheim; 1.2.2007; appl. 14.7.2006; DE-prior. 17.10.2003).
-
crystalline forms of Afatinib di-maleate:
- Solca, F. et al., J. Pharmacol. Exp. Ther., (2012) 343(2), 342-350.
- WO 2013 052157 (Ratiopharm/Teva; 11.4.2013; appl. 25.4.2012; USA-prior. 6.10.2011).
GSK/Isis rare disease drug moves into Phase II/III
feb20,2013
GlaxoSmithKline is paying out $7.5 million to partner Isis Pharmaceuticals as an antisense drug being developed for transthyretin amyloidosis, “a severe and rare genetic disease,” goes into a Phase II/III study.
TTR amyloidosis is characterised by progressive dysfunction of peripheral nerve and/or heart tissues and affects 50,000 patients worldwide and current treatments are limited. The 15-month study of the drug, known as ISIS-TTRRx, will involve some 200 patients with familial amyloid polyneuropathy who experience TTR build-up in their peripheral nerves and experience the loss of motor functions, such as walking.
Lynne Parshall, chief operating officer at Isis, said that “the rapid development of ISIS-TTRRx from a research-stage programme to a drug in late-stage clinical development in just over two years represents the strong commitment of both teams”. She added that the encouraging data from a Phase I study, “in which our drug was well tolerated and produced significant reductions in TTR protein, supported the advancement of ISIS-TTRRx directly into this registration-directed Phase II/III study”.
The drug is part of an Isis-GSK strategic alliance to develop RNA therapeutics for rare and infectious diseases. That pact was recently amended and apart from the $7.5 million fee, Isis is eligible to earn an additional $50 million to support the study, plus regulatory and sales milestone payments, plus double-digit royalties.
Chelsea encouraged by FDA talks on Northera(droxidopa)
(2R,3S)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid
L-DOPS (L-threo-dihydroxyphenylserine; Droxidopa; SM-5688) is a psychoactive drugand synthetic amino acid precursor which acts as a prodrug to the neurotransmittersnorepinephrine (noradrenaline) and epinephrine (adrenaline).[1] Unlike norepinephrine and epinephrine themselves, L-DOPS is capable of crossing the protective blood–brain barrier(BBB).[1]
L-DOPS was developed by Sumitomo Pharmaceuticals under the trade name Droxidopafor the treatment of hypotension, including NOH,[2] and NOH associated with variousdisorders such as MSA, FAP, and PD, as well as IDH. The drug has been used in Japanand some surrounding Asian areas for these indications since 1989. Following a merge with Dainippon Pharmaceuticals in 2006, Dainippon Sumitomo Pharma licensed L-DOPS to Chelsea Therapeutics to develop and market it worldwide except in Japan, Korea, China, and Taiwan.
Clinical trials
Though L-DOPS has been used in Japan and Southeast Asia already for some time, it is also currently in clinical trials at the phase IIIpoint in the United States (U.S.), Canada, Australia, and throughout Europe. Provided L-DOPS successfully completes clinical trials, it could be approved for the treatment of NOH as early as 2011.[4] Additionally, phase II clinical trials for IDH are also underway. Chelsea Therapeutics obtained orphan drug status (ODS) for L-DOPS in the U.S. for NOH, and that of which associated with PD, PAF, and MSA, and is the pharmaceutical company developing it in that country.
FEBRUARY 21, 2013
Shares in Chelsea Therapeutics International have leapt after the company said it will resubmit its previously-rejected treatment of neurogenic orthostatic hypotension, Northera, after helpful discussions with US regulators.
A year ago, the Food and Drug Administration issued Chelsea with a complete response letter asking for more data regarding its filing for Northera (droxidopa)for NOH. That came as something of a surprise given that the agency’s Cardiovascular and Renal Drugs Advisory Committee had earlier voted 7-4 in favour of the therapy.
Now Chelsea says that following a meeting, it has received written guidance from the Director of the Office of New Drugs at the FDA stating that an ongoing study has the potential to serve as the basis for a resubmission.
The guidance suggests that “data strongly demonstrating a short-term clinical benefit of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval”.
Encouraged by this, Chelsea plans to refile Northera in the late second quarter of 2013. Chief executive Joseph Oliveto said the firm looks forward to submitting the totality of our clinical experience to date to the agency for review…we now have a regulatory path forward”.
Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013.
- Goldstein, DS (2006). “L-Dihydroxyphenylserine (L-DOPS): a norepinephrine prodrug”. Cardiovasc Drug Rev 24 (3-4): 189–203. doi:10.1111/j.1527-3466.2006.00189.x.PMID 17214596.
- Mathias, Christopher J (2008). “L-dihydroxyphenylserine (Droxidopa) in the treatment of orthostatic hypotension”. Clin Auton Res 18 (Supplement 1): 25–29. doi:10.1007/s10286-007-1005-z.
- Crofford, LJ (2008). “Pain management in fibromyalgia”. Curr Opin Rheumatol 20 (3): 246–250.doi:10.1097/BOR.0b013e3282fb0268. PMID 18388513.
- Search of: “Droxidopa” – List Results – ClinicalTrials.gov
- Robertson, David (2008). “The pathophysiology and diagnosis of orthostatic hypotension”. Clin Auton Res 18(Supplement 1): 2–7. doi:10.1007/s10286-007-1004-0.
ONO Pharmaceutcal files for approval of Additional Indication for Onoact® 50 injection, Short-Acting Selective β1 Blocker in Japan
disease. AF/AFL with LV dysfunction accompanying by persistent elevated heart rate would lead to further deterioration of cardiac performance. Swift rate control is inevitable to be restored from this detrimental condition, however, no drug on market can provide both the features of fast-acting and easy titratability for tachyarrhythmia (AF/AFL) with LV dysfunction.
Onoact® 50 for injection is the short-acting selective β1 blocker which reduces heart rate by selectively blocking β1 receptors located chiefly in the heart and this fast-acting drug can be easily titrated.
We expect that Onoact® 50 for injection can contribute to promptly reducing heart rate without causing deterioration of cardiac performance in treatment of tachyarrhythmia (AF/AFL) with LV dysfunction.
This short-acting selective β1 blocker drug is discovered and developed by ONO and has been widely used by many patients since its launch. The drug has firstly received approval for emergency treatment of intra-operative tachyarrhythmia (atrial fibrillation and flutter, and sinus tachycardia) in July 2002. Then, it had also been approved for additional indication of emergency treatment of post-operative tachyarrhythmia (atrial fibrillation and flutter, and sinus tachycardia) with monitoring of circulatory dynamics in October 2006.
| Identifiers | |
|---|---|
| CAS number | 133242-30-5 |
| Chemical data | |
| Formula | C25H39N3O8 |
| Mol. mass | 509.59 g/mol |
Landiolol (INN) is a drug which acts as a highly cardioselective, ultra short-acting beta blocker. It is used as an anti-arrhythmic agent.
- Yoshiya I (December 1998). “[Landiolol hydrochloride, a new sympathetic beta blocker]” (in Japanese). Masui 47 Suppl: S126–32. PMID 9921175.
- Ogata J, Okamoto T, Minami K (2003). “Landiolol for the treatment of tachyarrhythmia associated with atrial fibrillation”. Can J Anaesth 50 (7): 753. doi:10.1007/BF03018726. PMID 12944459
FDA Approves Natrelle 410 Breast Implant
Silicone gel-filled breast implants
Image/FDA
Feb. 20, 2013
The U.S. Food and Drug Administration (FDA) approved Allergan’s new silicone gel-filled breast implant today, making it the fourth FDA-approved silicone gel-filled breast implant product available in the U.S, according to an FDA news release Feb. 20.
The product, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, can be used increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
According to the FDA, the approval is based on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.
It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren.
The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.
Edison commences EPI-743 Vatiquinone Phase 2 study in cobalamin C deficient patients
19 February 2013
EPI-743 Vatiquinone is a new drug that is based on vitamin E. Tests have shown that it can help improve the function of cells with mitochondrial problems. It may be able to treat people with genetic disorders that affect metabolism and mitochondria
Edison Pharmaceuticals and Bambino Gesu Children’s Hospital have announced the commencement of EPI-743 Phase 2 cobalamin C deficiency syndrome trial.
EPI-743 is an orally bioavailable small molecule and a member of the para-benzoquinone class of drugs.
The trial’s principal investigator, Bambino Gesu Children’s Hospital, division of metabolism Professor Carlo Dionisi-Vici said, “Given the central role of glutathione in cellular redox balance and antioxidant defense systems, we are eager to explore whether a therapeutic that increases glutathione such as EPI-743 will provide clinical benefit.”
Improvement in visual function is the primary endpoint of the placebo-controlled study while secondary outcome measurements assess neurologic and neuromuscular function, glutathione biomarkers, quality of life, in addition to safety parameters.
The investigation is aimed at assessing the efficacy of EPI-743 in disorders of intermediary metabolism that also result in redox disturbances.
EPI-743 is an orally absorbed small molecule that readily crosses into the central nervous system. It works by targeting the enzyme NADPH quinone oxidoreductase 1 (NQO1). Its mode of action is to synchronize energy generation in mitochondria with the need to counter cellular redox stress
FDA approves UCLA IND application to commence embryonic stem cell-based trial
12 feb 2013
The USFDA has approved the investigator investigational new drug (IND) application of University of California, Los Angeles (UCLA), the clinical partner of Advanced Cell Technology (ACT), to commence a clinical trial using the human embryonic stem cells (hESCs)-derived cells to treat severe myopia.
Embryonic stem cell-based trial was designed to assess the hESC-derived ACT’s retinal pigment epithelial (RPE) cells in patients with severe myopia (nearsightedness).
ACT chairman and CEO Gary Rabin said, “We are pleased to be on track to broaden the scope of our RPE program with the initiation of the new Investigator IND.”
Human embryonic stem cells (hESCs) are pluripotent cells derived from the inner cell mass of the blastocyst. They have the ability to renew themselves and to differentiate into a variety of different cell types that are found in the body. Unlike somatic or ‘adult’ stem cells, hESCs proliferate indefinitely. This, together with their ability to differentiate into most adult cell types, has resulted in the preferred use of these cells for research and therapeutic applications, as they represent a potentially indefinite source of therapeutic cells. Any cell therapy derived from hESCs would be allogeneic by nature. Some current studies involve the potential therapeutic application of hESCs for spinal cord injury, age-related macular degeneration (AMD), cardiovascular diseases, and diabetes. Among the start up cell therapy companies, Geron and Advanced Cell Technologies have pioneered clinical trials using cells differentiated from hESCs.
New Drug Approvals