FDA saw early reports of severe Omontys reactions: WSJ

The anemia drug Omontys triggered serious allergic reactions long before February's recall, The Wall Street Journal reports. The Affymax ($AFFY) and Takeda Pharmaceutical anemia drug was linked with life-threatening anaphylaxis in adverse event reports last August, according to FDA records obtained by the newspaper.

In February, FDA announced a recall of all Omontys lots, citing reports of serious reactions, including three deaths. As the WSJ notes, the adverse event reports to FDA included 12 deaths in patients using the drug, but it's uncertain whether Omontys actually caused them. Takeda itself weighed 5 deaths in deciding whether to pull the drug, the Journal says.

Omontys won FDA approval last April as an anemia treatment for kidney patients on dialysis. It was hailed as the first head-to-head rival for Amgen's ($AMGN) multibillion-dollar anemia franchise. Amgen's Epogen and Aranesp have run into safety problems of their own, which has dented sales over the past several years, but the red flags on Omontys emerged rather quickly as use broadened.

By October, Affymax had asked FDA to add a warning of possible allergic reactions to the Omontys label. And soon after Fresenius rolled out Omontys to more of its dialysis centers earlier this year, it reported allergic reactions in 5 patients. Some two weeks later, Affymax and Takeda issued the recall.

Affymax CEO John Orwin said at the time that the company was investigating the problem and looking at the entire Omontys supply chain. As the WSJ notes, Orwin said his company wanted to know whether a manufacturing flaw triggered the reactions, or the drug itself. Obviously, a manufacturing flaw could be fixed more easily than the latter.

The question the WSJ report implies is whether Omontys should have been suspended last fall, rather than in February. Affymax was worried enough in October to ask for the labeling change, and that was before Omontys went into broader use at Fresenius and other dialysis centers. How many adverse-reaction reports should it take?

Affymax Chief Medical Officer Anne-Marie Duliege told the Journal that the company has followed FDA rules and that it's working with the agency now. FDA hasn't yet decided whether to allow Omontys back on the market.

- read the WSJ piece

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