In February 2013, both the firms have voluntarily recalled all lots of Omontys and suspended promotional activities in the US after postmarketing reports of serious hypersensitivity reactions including anaphylaxis, which may be life-threatening or fatal.
Takeda has carried out a detailed investigation of these reactions and the investigation has confirmed no quality or manufacturing issues were present but has not identified a specific root cause for the reactions that were observed.
Based on the findings and related discussions with Takeda, Affymax has chosen not to exercise its rights with respect to the Omontys New Drug Application (NDA).
Takeda said it will work with the US Food and Drug Administration (FDA) to withdraw the Omontys NDA.
Currently, board of directors of Affymax is reviewing its strategic options as a result of the termination of the collaboration with Takeda.