ARTICLE | Clinical News

Hematide peginesatide regulatory update

December 6, 2010 8:00 AM UTC

Affymax and partner Takeda said they plan to submit an NDA to FDA for Hematide peginesatide to treat anemia in chronic kidney disease (CKD) patients on dialysis in 2Q11 after the partners met with the agency to discuss the application. In August, the companies said that they planned to submit the NDA in 1H11. The partners will continue to evaluate the synthetic peptide-based erythropoiesis-stimulating agent (ESA) in non-dialysis patients. ...