FDA advisers vote in favour of Hematide (Takeda/Affymax) approval for Anaemia

The FDA's Oncologic Drugs Advisory Committee has voted 15 to 1 that Hematide (peginesatide), from Takeda and Affymax, demonstrate a favorable benefit/risk profile for use in the treatment of dialysis patients with Anaemia due to chronic kidney disease (CKD). While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application that was submitted by Affymax for Hematide in May 2011. The scheduled Prescription Drug User Fee Act date for Hematide is March 27, 2012.