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Spectrum Pharmaceuticals, Inc. (SPPI) Anemia Drug Works as Well as Approved Drugs, FDA Says



12/5/2011 8:39:55 AM

Affymax Inc. (AFFY)’s experimental anemia medicine works as well as treatments marketed by Amgen Inc. (AMGN) and Johnson & Johnson (JNJ) for patients with chronic kidney disease, U.S. regulators said. The shares jumped the most in 16 months. The therapy chemically known as peginesatide is “non- inferior” to Amgen’s Epogen and Aranesp and J&J’s Procrit, Food and Drug Administration staff evaluating whether the product should be sold said in a report today. Agency reviewers also concluded the treatment is as safe as Epogen and Procrit for people on dialysis, the patient group for whom Affymax seeks approval. An advisory panel is due to meet Dec. 7 to evaluate the findings.

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