Peginesatide Approval Introduces Competition into Antianemia Drug Market

Abstract

There’s a new player in anemia management for patients on dialysis— once-monthly peginesatide, which was approved by the Food and Drug Administration (FDA) on March 27. “In the United States where only epoetin alfa, as Epogen, and darbepoetin are available in the dialysis market, this represents a novel agent to compete with the existing agents in the marketplace,” said Nephrology Times Editorial Board Chair Ajay K. Singh, MBBS, MBA, in a phone interview. “It’s a major milestone.” Dr. Singh is Director of Global Programs and Associate Professor of Medicine at Harvard Medical School, as well as a physician in the Division of Renal Medicine and Director of Postgraduate Medical Education in the Department of Medicine at Brigham and Women’s Hospital. Peginesatide is given less frequently than epoetin alfa, which typically is administered one to three times a week. “The advantage is clearly the oncemonthly administration, putting a lot of convenience to the management of anemia,” said Brigitte Schiller, MD, Chief Medical Offi cer of Satellite Healthcare and a member of the Scientifi c Advisory Board of Affymax, which discovered peginesatide and is co-commercializing it in the United States with Takeda, under the brand name Omontys. “I would think of it as a simplifying anemia management approach for the nurses, the providers, and for patients,” Dr. Schiller said in a phone interview. Peginesatide Approval Introduces Competition into Antianemia Drug Market