The suppliers of a new drug to treat anemia in patients undergoing kidney dialysis have recalled all lots of the product after reports that it had caused severe allergic reactions, including some that were fatal.
Affymax and Takeda Pharmaceutical, which jointly market the drug, Omontys, or peginesatide, announced the recall late on Saturday, and the notice was also posted by the Food and Drug Administration.
The F.D.A. said in a news release on Sunday that it had received 19 reports of anaphylaxis, a severe allergic reaction, and that three of the patients had died, while others required prompt medical intervention or hospitalization.
Approved last March, Omontys broke the lucrative monopoly Amgen had since 1989 on treating anemia in dialysis clinics. While it is not clear yet what the recall means for the future of Omontys, it could help sales of Amgen's drug, Epogen.
Affymax and Takeda said that hypersensitivity reactions have been fatal in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval. That would suggest there have been five deaths, a slight discrepancy from the F.D.A. figures that was not explained. Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.
The companies and the F.D.A. said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration. No problems have been reported with subsequent doses, which are given once a month. Still, the companies and the F.D.A. advised that Omontys use be discontinued even by patients who have already had more than one dose.
The big question is whether this will cause the drug to be withdrawn from the market. It is possible that doctors can act to avert or lessen allergic reactions on the first dose. It is also possible the problems are confined to certain dialysis centers.
A spokeswoman for Affymax said executives would not comment further until a conference call for securities analysts on Monday morning. Omontys is the only marketed product for Affymax, which is based in Palo Alto, Calif., and licensed commercialization rights to Takeda, Japan's largest pharmaceutical company.
Reports of severe allergic reactions have been accumulating, and the Omontys label warns of them, as does the Epogen label.
This month, Fresenius Medical Care North America, the nation's largest dialysis provider, halted a pilot program testing Omontys, in part because of these allergic reactions. The company said in a memorandum that it had treated 18,000 patients with the drug and would now analyze the data.
"To date, we have seen infrequent allergic reactions in our patient population receiving their first dose of Omontys," said the Feb. 13 memo by Fresenius's chief medical officer and its associate chief medical officer. They recommended that patients already taking Omontys continue and said dialysis centers could also put new patients on it.
The memo was made public in a regulatory filing by Affymax.
Sales of Omontys for the nine months it was on the market were $34.6 million, compared with $1.5 billion for Epogen. Still, Affymax executives have said Omontys was gaining momentum because of its less-frequent dosing, lower cost and the desire of some dialysis center owners for an alternative to Amgen.
Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, said that unless the problem was because of contamination, "this could easily lead to withdrawal of drug approval." He said that "two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this" with Epogen.
Dr. Ajay K. Singh, a kidney specialist at Brigham and Women's Hospital in Boston, said that the recall should result in "minimal disruption" because centers could use Epogen or another Amgen drug, Aranesp. But he said it might be hard for Affymax and Takeda, which is based in Osaka, to show the safety of their drug without a huge study.
Amgen's Epogen is a synthetic version of the human protein erythropoietin, or EPO, which stimulates the body to produce oxygen-carrying red blood cells. Omontys is not EPO, but binds to the same receptor in the body.
Sales of Amgen's Epogen have been declining because of changing financial incentives for dialysis clinics and because of safety concerns, particularly those related to blood clots and heart attacks. EPO has also become known for secretly being used by athletes like Lance Armstrong.
The next competition to Epogen could come from Roche's Mircera, a form of EPO, in mid-2014. Biosimilars, or near-generic forms of Epogen, could reach the market after Amgen's last patent expires in 2015.
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