peginesatide

Separately, the committee voted 15-1, with one abstention, to recommend approval of a new drug called peginesatide for treatment of anemia in dialysis patients.

Pfizer Kidney Cancer Drug Gets FDA Panel's Nod Thomas M. Burton 2011

In review documents released on Monday, U.S. Food and Drug Administration staff said uncertainty over the safety of Affymax's treatment, known as peginesatide, remained a "major concern" from its clinical trials.

Reuters: Press Release 2011

The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia with a similar adverse event rate.

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Affymax and Takeda Pharmaceutical North America are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States.

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In the studies, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin.

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The company had announced on July 27, 2011 that the FDA accepted the peginesatide NDA submission for review.

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This release contains forward-looking statements, including statements regarding the continuation and success of Affymax's collaboration with Takeda, milestones expected to be accomplished, timing, design and progress of the peginesatide development program and the timing and potential regulatory approval and commercialization of peginesatide.

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If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent ESA available for the treatment of anemia associated with CKD patients on dialysis in the United States.

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The NDA included data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels.

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"The peginesatide New Drug Application represents an important step in the evaluation of this potential new treatment for the many dialysis patients impacted by this common condition."

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