Takeda and Affymax recall all lots of anemia drug Omontys

25 February 2013

US drugmaker Affymax (Nasdaq: AFFY) and its licensee, Japan’s Takeda Pharmaceutical (TYO: 4502), said on Sunday that they have decided to voluntarily recall all lots of Omontys (peginesatide) Injection to the user level as a result of new post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.

The companies say they have been working actively with the US Food and Drug Administration, which approved the drug last year for the treatment of anemia due to chronic kidney disease (The Pharma Letter March 28, 2012), adding that the agency has indicated its agreement with this decision.

The drugmakers have also issued a letter to health care professionals indicating that no new or existing patients should receive Omontys, which had been projected as having a peak sales potential of $700 million a year, and is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the dialysis patient population with chronic kidney disease (CKD) in the USA..

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