Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection

Affymax AFFY and Takeda Pharmaceutical Company TKPYY decided on Saturday to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been working actively with the U.S. Food and Drug Administration (FDA) which has indicated its agreement with this decision. The companies have also issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The See full press release