Affymax ($AFFY) has been part of a "David and Goliath" story for years, with the small biotech developing an anemia drug called peginesatide for kidney dialysis patients that could rival Epogen, from industry giant Amgen ($AMGN), if approved. FDA advisers are meeting Dec. 7 and will decide whether to recommend the drug for approval, Xconomy reported. It's a crucial event for Affymax as the advisory committee's votes will weigh into the agency's decision on the drug expected in the first quarter of next year.
Last year, our "David" got its butt kicked. Affymax, which has partnered with Takeda on peginesatide, revealed some increases in cardiovascular risks in a group of patients who were among 2,609 participants in its four late-stage trials of its drug. The company's share value was beaten down and hasn't fully recovered since those data were reported. But Affymax CEO John Orwin, a former Genentech employee who took the reins at the company Feb. 1, sounded upbeat about the benefits of the drug and the cardio risks to patients in his interview with Xconomy's Luke Timmerman.
For instance, peginesatide, an erythropoiesis stimulating agent, is injected just once a month, meaning dialysis patients would have to endure fewer needles than they would taking more frequent injections of Epogen, Xconomy reported. The drug could also be cheaper to produce than Epogen, Amgen's blockbuster anemia therapy. As for the cardio risks, Orwin told the online news site that cardio side effects weren't elevated in two of the four pivotal trials of the drug.
"Just having a competitive alternative to EPO for the first time in 22 years will make peginesatide attractive," Orwin told Xconomy. "I think customers would be interested."
The FDA's PDUFA date for action on Affymax's application for approval of peginesatide is March 27.
- get more in Xconomy's article
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