US FDA to give verdict on Affymax, Takeda ESA in March
This article was originally published in Scrip
Executive Summary
The US FDA assigned 27 March 2012 as the Prescription Drug User Fee Act (PDUFA) action date Affymax's and Takeda's new drug application for peginesatide, a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).