NEXAVAR GETS POSITIVE OPINION FROM CHMP
The European Committee for Medicinal Products for Human Use (CHMP) has granted Bayer and Onyx Pharmaceuticals a positive opinion for Nexavar (sorafenib) — a treatment for patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy.
" This positive opinion from the CHMP — received earlier than originally anticipated — marks another important milestone, bringing us one step closer to the global launch of Nexavar," noted Gunnar Riemann, head of Bayer HealthCare's pharmaceuticals division.
The positive CHMP opinion will be elevated to the European Commission where a positive ruling could lead to marketing authorization for all countries in the EU in the second half of 2006. Nexavar was approved by the U.S. FDA in December 2005. Bayer has filed drug applications in several other countries, including Australia, Brazil, Canada, and Turkey.