Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, and Affymax Inc. (AFFY) have voluntarily recalled an anemia treatment for kidney dialysis patients after reports of “serious hypersensitivity reactions” that could be fatal.
All lots of Omontys, sold in 10mg and 20mg vials, have been recalled and health care professionals have been told patients shouldn’t receive the drug, the companies said in a statement. The U.S. Food and Drug Administration, which approved Omontys in March last year, agreed to the recall, they said.
“Our company is working with the FDA and Affymax and decided to voluntarily recall Omontys to put patients’ safety first,” said Kazumi Kobayashi, a spokesman for Osaka-based Takeda. “We will swiftly provide information to patients and health care professionals.”
Affymax fell 6.9 percent in Nasdaq trading on Feb. 14 after the drugmaker said Fresenius Medical Care North America will pause expansion of a pilot program using Omontys. Fresenius saw “infrequent” allergic reactions in patients receiving a first dose, according to the filing. The stock rebounded 5.7 percent a day later after analysts including Christopher Raymond of Robert W. Baird & Co. said it had been oversold.
Sales of Omontys tripled to $19 million in January, according to Symphony Health’s data.