FDA Panel Supports Peginesatide
Affymax-Inc-Takeda-Pharmaceuticals

On Wednesday, Affymax Inc. and Takeda Pharmaceutical Co. announced that an advisory committee of the US Food and Drug Administration has decided to support Peginesatide and applauded its attributes for treating people living on dialysis due to chronic kidney disease, especially those who have developed anemia.

Sources have notified that the experimental drug is likely to offer a tough competition for the blockbuster anemia drug Epogen of Amgen Inc., in case it succeeded in receiving approval from the US Food and Drug Administration. Affymax and Takeda Pharmaceutical are also believed to have a role in its development.

In 1989, the Epogen was credited to be the very first ESA that succeeded in availing approval from the FDA for treating anemia in people living with renal diseases. Afterwards in 1993, the drug received approval for a supplemental indication and experts started recommending it for treatment of anemia related to cancer chemotherapy.

"We think Amgen could lose a theoretically realistic range of dialysis market share of 10 to 50 percent, and we believe the likely financial EPS (earnings per share) impact is roughly $0.02”, said a biotechnology analyst with RBC Capital Markets LLC in San Francisco, Michael Yee, while commenting on the panel's review. In addition, Michael also anticipated that there are abundant chances for the drug to receive an approval from FDA.

On the other hand, Amgen also commented on the panel vote and tagged Epogen as well as Aranesp as most vital drugs to regulate anemia for chronic kidney disease patients. In a media release, the President and Chief Executive Officer of Affymax, John Orwin has applauded the decision of the panel. Further, John Orwin claimed that the decision has encouraged the company for developing better measures. The FDA is expected to make a decision on the matter by March 27.

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