Bayer and Onyx Announce Nexavar® (sorafenib tosylate) Tablets as Global Trade Name for Investigational Cancer Treatment
Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced the selection of Nexavar® (sorafenib tosylate) Tablets as the global trade name for sorafenib, the oral investigational drug under FDA review for the treatment of advanced renal cell carcinoma (RCC), or kidney cancer.
Bayer and Onyx filed a New Drug Application (NDA) in July 2005 requesting approval in advanced renal cell cancer by the U.S. Food and Drug Administration (FDA). Subsequently, the FDA granted the Nexavar filing priority review status, which means the FDA intends to make a determination within six months of when they received the NDA. Additionally in September 2005, a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) to market Nexavar in Europe. If approved, Nexavar will be marketed by Bayer and Onyx through a co-promotion and co-development agreement.
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