Reuters: Regulatory News: UPDATE 1-EU body backs new Roche, Astellas, Sanofi, Vivus drugs

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UPDATE 1-EU body backs new Roche, Astellas, Sanofi, Vivus drugs Apr 26th 2013, 12:23 Fri Apr 26, 2013 8:23am EDT LONDON, April 26 (Reuters) - European regulators have recommended approval of two new cancer drugs, called Erivedge and Xtandi, from Roche and Astellas, underscoring a recent pick-up in novel treatments for the disease. Erivedge is the first medicine for people with advanced forms of basal cell carcinoma, the most common skin cancer, and was approved in the United States in January. Curis, Roche's partner, is entitled to certain payments on the drug. Xtandi, which Astellas has been working on with Medivation , is designed to treat prostate cancer in men whose cancer has spread despite treatment with hormone therapy and chemotherapy. It won U.S. approval last August. The European Medicines Agency said on Friday its experts had also backed MAC1, a tissue-engineered medicine for cartilage defects from Sanofi's Genzyme unit, and Spedra, a new erectile dysfunction drug from Vivus. Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. In addition, the London-based agency recommended approval for extended use of Celgene's blood cancer drug Revlimid and Roche's rheumatoid arthritis treatment RoActemra. The news was less good for Pfizer, whose new arthritis pill Xeljanz received a surprise rejection from the EMA, as announced by the company late on Thursday. Link this Share this Digg this Email Reprints

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