Monday, July 1, 2013

Takeda Withdraws Peginesatide MAA due to hypersensitivy reactions observed in the US

Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its wholly-owned subsidiary Takeda Development Centre Europe Ltd. has withdrawn the European Marketing Authorization Application (MAA) for peginesatide solution for injection, which was intended to be used for treatment of symptomatic anaemia associated with chronic kidney disease in adult patients undergoing dialysis.
In February, Takeda voluntarily recalled all lots of peginesatide from the US market as a result of new post-marketing reports of serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.While the company has been working actively to investigate the root cause of these hypersensitivity reactions, the investigation is currently ongoing and a root cause analysis and determination of a risk mitigation plan will not be complete during the European MAA procedure timeframe. Therefore Takeda has made the decision to withdraw the European MAA and determine at a later date the appropriate direction for the product. 




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