July 7, 2014 — Law360 reports that Affymax, the pharmaceutical company behind the anemia drug Omontys (peginesatide), has agreed to pay $6.5 million to settle a class action lawsuit alleging that the drug-maker knowingly misled investors about the safety risks of Omontys.
Omontys was the first once-monthly injectable erthyropoiesis-stimulating agent for dialysis patients with anemia. The drug worked by stimulating the bone marrow to produce red blood cells.
Affymax and Takeda Pharmaceuticals, Japan’s largest drug-maker, voluntarily recalled Omontys in February 2013 after it was linked to severe, life-threatening hypersensitivity reactions.
Some patients developed anaphylaxis, which is a severe, whole-body allergic reaction to a chemical in the body. Tissues in the body swell rapidly, including the airway. A total of 98 adverse events were reported, including 12 deaths.
According to the recall:
“The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.”
Takeda conducted a thorough investigation of the hypersensitivity reactions. They found no problems with quality or manufacturing processes.
Takeda and Affymax also terminated their collaboration and are working with the U.S. Food and Drug Administration (FDA) to withdraw approval of the drug. Omontys was the only drug manufactured by Affymax, and last month, the board of directors approved liquidation and dissolution of the company.