Breaking News From Pharma & Bio Ingredients Subscribe via RSS Subscribe via RSS



Nexavar Wins Approval in Switzerland


Posted on 2006-03-30 09:04:00



Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN). Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in Switzerland.

"The approval of Nexavar in Switzerland marks an important step in the brand's entry into Europe. We are pleased with the decision by Swissmedic, and proud that we can now make this therapy available to physicians and patients in this region," said Dr. Gunnar Riemann, Head of Bayer HealthCare's Pharmaceuticals Division.

Nexavar was approved by the U.S. Food and Drug Administration (FDA) in December 2005. In September 2005, Bayer filed for regulatory approval with the European Medicines Agency (EMEA). Pending a favorable review, market availability is possible in the EU countries in the second half of 2006. In addition, Bayer has completed filings in several countries, including Mexico, Australia, Brazil, Canada and Turkey.