Drugmakers Affymax ($AFFY) and Takeda are investigating whether manufacturing is playing a role in the allergic reactions that have resulted in three deaths and led them to recall all of their anemia drug Omontys from the market.
The reactions were noted by Fresenius, which had been testing the drug in a pilot program in its dialysis clinics with Affymax and Takeda. Affymax CEO John Orwin, in a conference call Monday, said the company has been unable to figure out what is leading to the reactions. The problem was not specific to a single lot, Orwin said.
"At this point we have not identified the root cause of the problem but we will be looking at drug product in all its forms and at all stages, manufacturing, distribution, supply chain and handling at the sites," Orwin said. "We will look at every aspect of the product and the way it has been given."
Affymax and Japanese drugmaker Takeda have been collaborating since 2006 on Omontys, the only monthly treatment for anemia in dialysis patients. At the J.P. Morgan Health Conference in January, Affymax executives said their company was responsible for marketing and sales of Omontys and that Takeda was handling manufacturing.
|Affymax CEO John Orwin|
The serious hypersensitivity reactions, including anaphylaxis, have occurred in 0.2% of some 25,000 patients who have received first-dose injections of Omontys, Takeda and Affymax said in a statement. The FDA says it received reports of 19 serious reactions; three of those patients died. "Serious and fatal" hypersensitivity reactions have been reported in some patients within 30 minutes of receiving their first doses of the drug by intravenous injection, the companies. There have been no reports of reactions in patients receiving subsequent doses, in patients receiving the drug subcutaneously nor in patients who have finished their dialysis session.
In January, Affymax officials were saying that Omontys, which was approved by the FDA in March 2012, would break the monopoly that Amgen ($AMGN) has had on the market. They said they were building a "world-class commercial organization" and looking forward to developing another product. Now the company's future is in question. A kidney specialist at Washington University told The New York Times that if the problem is contamination, Affymax and Takeda can do something about it. If not, it could force Affymax to withdraw the drug because "two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this," with the competing Epogen from Amgen.
- read the Affymax announcement sent by the FDA
- more from The New York Times (sub. req.)