Takeda To Withdraw NDA for Anemia Drug OmontysBy
Affymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) will terminate their product collaboration and license agreement for
Omontys (peginesatide), a drug to treat anemia due to chronic kidney disease in adult patients on dialysis, effective September 10, 2014.
In February 2013, Affymax and Takeda voluntarily recalled all lots of Omontys and suspended promotional activities in the US following postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, which may be life-threatening or fatal. The drug had initially been approved by FDA in 2012.
Takeda has conducted a detailed investigation of these reactions. The investigation has confirmed that no quality or manufacturing issues were present, but the company has not identified a specific root cause for the reactions that were observed.
Based on these findings and related discussions with Takeda, Affymax has elected not to exercise its rights with respect to the Omontys new drug application (NDA). Takeda will work with the US Food and Drug Administration to withdraw the Omontys NDA. The drug had initially been approved by FDA in 2012.
The Board of Directors of Affymax is reviewing its strategic options as a result of the termination of the collaboration with Takeda.
Source: Takeda Pharmaceutical Company