FDA Panel Votes in Favor of Affymax Anemia Drug

A federal panel has voted 15-1 in favor of recommending the FDA approval of Affymax's anemia drug peginesatide, according to a Dec. 7 report from the San Francisco Business Times.

The panel found that the drug's "risks do not outweigh its benefits for dialysis and non-dialysis patients with chronic kidney disease. One member of the panel abstained," according to the report.

Despite the vote in favor of peginesatide, the FDA is not required to follow the recommendation. The San Francisco Business Times reported that the FDA is expected to make its decision by March 27.

If approved, peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with CKD patients on dialysis in the United States, according to Affymax.

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if it is approved in the United States. The product, upon approval, will be commercialized outside the United States by Takeda.

Peginesatide could challenge Amgen's anemia drugs Epogen and Aranesp if it is approved. And Amgen may have already seen the competitive potential as it signed multi-year deals with the United States' two largest dialysis providers. Epogen sales alone total around $2.5 billion annually.

In mid-November, DaVita signed  a supply agreement with Amgen under which Epogen will account for at least 90 percent of the dialysis provider’s anemia drug requirements through 2018. In addition, Amgen and Fresenius signed  a "multi-year" agreement that starts in January  to supply Epogen on a "nonexclusive" basis, according to a Nov. 18 Reuters report.

Today's decision is an important milestone for Affymax, and although Amgen has worked to protect its product in the year's to come, it seems the deals have some wiggle room that could allow Affymax's peginesatide to gain a foothold.

If Affymax gets their product approved, the coming years of anemia management should get interesting with bundling in full swing and the quality incentive program (QIP) set to start in 2012.