Home » EU PIPELINE (Page 5)
Category Archives: EU PIPELINE
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Recent Comments
 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
EU OKs Blood Cancer Drug Iclusig
ponatinib
ARIAD Announces Marketing Authorization for Iclusig® (ponatinib) in the European Union
CAMBRIDGE, Mass. & LAUSANNE, Switzerland–(BUSINESS WIRE)–Jul. 2, 2013– ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the European Commission (EC) has granted a marketing authorization for Iclusig® (ponatinib) as an orphan medicinal product for two indications:read all at
http://www.pharmalive.com/eu-oks-blood-cancer-drug-iclusig
Ponatinib (Iclusig, previously AP24534) is an FDA approved oral drug candidate developed by ARIAD Pharmaceuticals for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). It is a multi-targeted tyrosine-kinase inhibitor. Some forms of CML, those that have the T315I mutation, are resistant to current therapies such as imatinib. Ponatinib has been designed to be effective against these types of tumors.
Oncologists have complained, however, that many patients can’t afford the “astronomical” cost of $138,000 a year, which makes it one of the most expensive drugs in medicine, and far more expensive than what is needed to pay the development costs.
Ponatinib was approved by the US FDA on December 14, 2012, for patients with resistant or intolerant CML and Ph+ ALL, based on results of the PACE phase II trial reported days earlier at the annual ASH meeting.Because the approval was under the FDA’s accelerated approval program the applicant will be required to carry out additional studies.
The PACE (Ponatinb Ph+ ALL and CML Evaluation) pivotal phase II trial started enrolling patients in September 2010 and is designed to provide definitive clinical data for regulatory approval in this setting. Good results were reported in Dec 2012.
At the 2010 annual meeting of the American Society of Hematology, ARIAD announced from a Phase I study of ponatinib in patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). The study demonstrated that in chronic-phase CML patients treated with ponatinib, 66 percent of patients in the trial achieved a major cytogenetic response, including 100 percent of patients who also had a T315I mutation
VIVUS Announces SPEDRA (avanafil) Approval in Europe
AVANAFIL
June 26, 2013
VIVUS, Inc. today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA(TM) (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2013.
SPEDRA, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade. The global market for ED therapies was approximately $5.5 billion in 2012.
About Avanafil
STENDRA, or avanafil, is approved by the FDA for the treatment of erectile dysfunction, or ED, in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries.
VIVUS is currently in discussions with potential partners to commercialize STENDRA in the United States and other territories throughout the world.
It is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit www.Stendra.com.
EU OKs Nuedexta for PBA
Avanir Pharmaceuticals, Inc. today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.
http://www.pharmalive.com/avanir-pharmaceuticals-announces-european-approval-of-nuedexta
NUEDEXTA is an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination.
Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α)- hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NO•HBr•H2O with a molecular weight of 370.33. The structural formula is:
Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-ol, 6’-methoxy- (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2•H2SO4•2H2O with a molecular weight of 782.96. The structural formula is:
The combination product, NUEDEXTA, is a white to off-white powder. NUEDEXTA is available for oral use as NUEDEXTA which contains 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate. The active ingredients are dextromethorphan hydrobromide monohydrate USP and quinidine sulfate dihydrate USP.Inactive ingredients in the capsule are croscarmellose sodium NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, lactose monohydrate NF, and magnesium stearate NF.
Astellas’ Xtandi approved in EU for prostate cancer
enzalutamide
XTANDI
Regulators in European have given the green light to Astellas Pharma and Medivation’s oral prostate cancer drug Xtandi.
Specifically, the European Commission has approved Xtandi (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. The thumbs-up comes a couple of months after the European Medicines Agency’s Committee for Human Medicinal Productsissued a positive recommendation on the treatment….. READ ALL AT
http://www.pharmatimes.com/Article/13-06-24/Astellas_Xtandi_approved_in_EU_for_prostate_cancer.aspx
Enzalutamide (marketed as Xtandi and formerly known as MDV3100) is an androgen receptor antagonist drug developed by the pharmaceutical company Medivation for the treatment of metastatic castration-resistant prostate cancer. Medivation has reported up to an 89% decrease in prostate specific antigen serum levels after a month of taking the medicine. Early preclinical studies also suggest that enzalutamide inhibits breast cancer cell growth. In August of 2012, the U.S. Food and Drug Administrationapproved enzalutamide for the treatment of castration-resistant prostate cancer.
Enzalutamide was discovered by Charles Sawyers who is now at Memorial Sloan–Kettering Cancer Center and Michael Jung at UCLA.
A model of the interaction between the prostate cancer drug enzalutamide and the androgen receptor
Celgene saw the firm get European approval for Revlimid as a treatment for a rare form of blood disease
lenalidomide
European Commission has expanded approval on Revlimid (lenalidomide) to allow treatment of patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes (MDS) with an isolated chromosomal abnormality called deletion 5q when other options do not work. MDS is a type of cancer where the production of blood cells and platelets by the bone marrow is disrupted, which can often lead to severe anemia, infections and bleeding.
Vitaros Approved in 10 Countries
Vitaros, alprostadil
7-[(1R,3R)-3-hydroxy-2-[(1E,3S)-3-hydroxyoct-1-en-1-yl]-5-oxocyclopentyl]heptanoic acid
Apricus Biosciences Inc. said that its impotence drug Vitaros has been approved in 10 European countries. The company said Vitaros is now approved in the Netherlands, Germany, France, Italy, and the U.K., among other countries, for the treatment of erectile dysfunction.
The active ingredient in Vitaros, alprostadil, is an ingredient in other approved impotence treatments and Apricus is also studying it as a treatment for female sexual arousal disorder.
Prostaglandin E1 (PGE1), known pharmaceutically as alprostadil,[1] is a prostaglandin. It is a drug used in the treatment of erectile dysfunction[2] and has vasodilatory properties.
Patent ductus arteriosus
Alprostadil is also used in maintaining a patent ductus arteriosus in newborns. This is primarily useful when there is threat of premature closure of the ductus arteriosus in an infant with ductal-dependent congenital heart disease, including cyanotic lesions (e.g., pulmonary atresia/stenosis, tricuspid atresia/stenosis, transposition of the great arteries) and acyanotic lesions (e.g., coarctation of the aorta, hypoplastic left heart syndrome, critical aortic stenosis, interrupted aortic arch).
Sexual dysfunction
Alprostadil is sold in the United States as urethral suppositories and in injectable form. The suppositories are sold under the brand name MUSE.[3] The injectable forms are Edex[4] and Caverject.[5] Muse delivers alprostadil as a penile suppository, inserted into the urethra, at least ten minutes before the erection will be needed. Caverject and Edex are similarly fast-acting, but instead are injected by syringe directly into the corpus cavernosum of the penis.
Apricus Biosciences is developing proprietary drugs; Vitaros for men with erectile dysfunction, Femprox for female sexual arousal disorder and RayVa for Raynaud’s phenomenon. Two Phase III studies have been completed for Vitaros, and approval has been granted in Canada. Apricus Biosciences is seeking regulatory approval in Europe, South America, and other territories. Apricus Biosciences sold the rights for Vitaros in the US to Warner Chilcott.[6]
Alprostadil is also available as a generic. The major cost is that it must be mixed by a compounding pharmacy and supplies of alprostadil may be difficult to obtain. There are different formulations, including Bimix and Trimix, which may include papaverine and/or phentolamine. A typical mix might be 30 mg of papaverine, 2 mg of phentolamine, and 20 mcg alprostadil. As a generic, it is much less expensive than the pre-packaged injectables. It is premixed and must be kept refrigerated and the user must load a syringe with the quantity needed.
Critical limb ischemia
Alprostadil is also used for critical limb ischemia. It increases blood flow by peripheral vasodilation within 5 minutes and induces angiogenesis. It is most effective when the ankle pressure is at least 30 mmHg and at least one tibial artery is patent.
- Cawello W, Leonhardt A, Schweer H, Seyberth HW, Bonn R, Lomeli AL (September 1995). “Dose proportional pharmacokinetics of alprostadil (prostaglandin E1) in healthy volunteers following intravenous infusion”. British Journal of Clinical Pharmacology 40 (3): 273–6. PMC 1365109. PMID 8527291.
- Harding LM, Adeniyi A, Everson R, Barker S, Ralph DJ, Baranowski AP (December 2002). “Comparison of a needle-free high-pressure injection system with needle-tipped injection of intracavernosal alprostadil for erectile dysfunction”. International Journal of Impotence Research 14 (6): 498–501. doi:10.1038/sj.ijir.3900916. PMID 12494285.
- “Muse Suppository – Facts and Comparisons”. Drugs.com. Retrieved 4 January 2013.
- Edex – Facts and Comparisons Drugs.com
- Caverject – Facts and Comparisons Drugs.com
- Fain Hughes (2007-10-29). “NEXM: Dutton Sees Strong Speculative Buy and 12-Month Price Double”. Retrieved 2007-11-01.
Prostaglandin E1 (alprostadil, PGE1) erectile dysfunction drug, molecular model. PGE1 is a prostaglandin used in the treatment of erectile dysfunction.
Sanofi Updates Lantus Label in EU, ORIGIN Results on Lantus® Cardiovascular Safety Integrated Into European Union Product Label
Lantus® (insulin glargine)
June 5, 2013 –
Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for inclusion in the Lantus® (insulin glargine) product label of safety and efficacy data from the insulin glargine cardiovascular (CV) outcomes trial ORIGIN (Outcome Reduction with Initial Glargine INtervention). The revised label is evidence of Sanofi’s ongoing commitment to further assert the well-known safety and efficacy profile of insulin glargine, the most-studied basal insulin. The indication for the use of Lantus® remains unchanged.
| Mechanism of Action |
|---|
 |
| Insulin glargine (lantus) mechanism of action. |
LANTUS (insulin glargine rdna origin injection) consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine rdna origin injection) contains 100 IU (3.6378 mg) insulin glargine.
LANTUS® is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent., LANTUS (insulin glargine rdna origin injection) is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acidasparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A– Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063.
New Rule on Importing Active Pharmaceutical Ingredients (API) to the EU
READ ALL AT
http://ec.europa.eu/health/files/documents/active_pharmaceutical_
by WORLD DRUG TRACKER
DR ANTHONY CRASTO
Novo Nordisk Files for Regulatory Approval of Ideglira in the EU
May 31, 2013) – Novo Nordisk today announced the submission to the European Medicines Agency of the marketing authorisation application for the approval of IDegLira, the combination product of insulin degludec (Tresiba®), the once-daily new-generation basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza®), the once-daily human GLP-1 analogue. IDegLira has been developed for the treatment of people with type 2 diabetes.
Incivo (Telaprevir) Receives European Commission Approval for Twice Daily Dosing for Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV)
TELAPREVIR
may 31, 2013
Incivo (Telaprevir) Receives European Commission Approval for Twice Daily Dosing for Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV)
Janssen Infectious Diseases-Diagnostics BVBA (Janssen) announced today that the European Commission (EC) has approved a new twice daily (BID) dosing of INCIVO(R) (telaprevir), a direct acting antiviral (DAA) protease inhibitor, in combination with pegylated-interferon and ribavirin (PR) for naive and previous treatment experienced patients. The newly approved dosing regimen for INCIVO(R) is now 1,125 mg twice daily in combination with PR, which aligns a morning and evening dose to the already twice daily dosing schedule for ribavirin versus 750 mg every 8 hours in combination with PR.
Telaprevir (VX-950), marketed under the brand names Incivek and Incivo, is a pharmaceutical drug for the treatment of hepatitis C co-developed by Vertex Pharmaceuticals and Johnson & Johnson. It is a member of a class of antiviral drugsknown as protease inhibitors. Specifically, telaprevir inhibits the hepatitis C viral enzymeNS3.4A serine protease. Telaprevir is only indicated for use against hepatitis c genotype1 viral infections and hasn´t been proven to have an effect on or being safe when used for other genotypes of the virus. The standard therapy of pegylated interferon and ribavirin is less effective on genotype 1 and telaprevir offers a welcome addition to the treatment of this genotype.
New Drug Approvals 