Approvals in Europe for Ipsen's Decapeptyl, and Novartis and Sanofi flu drugs

French drugmaker Ipsen says that the French regulatory authorities, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has granted a marketing authorization for its six-month sustained-release formulation of Decapeptyl (triptorelin embonate 22.5mg) for the treatment of locally-advanced and metastatic prostate cancer. The launch of the six-month formulation in France by Ipsen should take place during the first semester of 2010.

Last October, Ipsen and Debiopharm Group announced the successful completion of the European decentralized registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and the Netherlands while, for other European countries (Portugal, UK, Ireland, Italy, Romania and Lithuania), the marketing authorization applications were filed as a national line extension to the existing Decapeptyl's ones. France is the first country to approve Decapeptyl six-month in the context of the decentralized procedure in Europe.

Celtura cleared in German and Switzerland

Meantime, Swiss drug major Novartis announced that it had received German regulatory authority's approval for its adjuvanted Influenza A (H1N1) 2009 monovalent vaccine, Celtura. The approval is based on clinical trial results in 1,850 individuals that demonstrated strong efficacy and immune response in individuals aged 3 to 50 years.  The company also gained approval this month to market the product in Switzerland.

Celtura is manufactured in Marburg, Germany, and is an MF59 adjuvanted inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus. The vaccine contains 3.75mcg of antigen and 0.125ml of MF59. It will be offered in multi-dose vials and in single-dose pre-filled syringes. Novartis says it continues to pursue registration in other major countries, including Japan.

Panenza OKed in France

Additionally, the French drug regulatory agency Afssaps has granted marketing authorization for Panenza, domestic drug major Sanofi-Aventis' non-adjuvanted Influenza A (H1N1) 2009 monovalent vaccine. The vaccine has been made available to French health authorities.