LONDON, UK I June 28, 2013 and OSAKA, Japan I July 1, 2013 I 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 has withdrawn the European Marketing Authorization Application (MAA) for peginesatide solution for injection, which was intended to be used for treatment of symptomatic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 postmarketing 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.
About Takeda Development Centre Europe Ltd.
Based in London, England, Takeda Development Centre Europe Ltd., (TDC Europe), is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TDC Europe seeks to bring innovative products to people through a pipeline that includes compounds in development for diabetes, cardiovascular disease, neurology, oncology and other conditions. To learn more about the company, visit www.tdceurope.euAbout Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
SOURCE: Takeda Pharmaceutical Co
Post Views: 199
LONDON, UK I June 28, 2013 and OSAKA, Japan I July 1, 2013 I 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 has withdrawn the European Marketing Authorization Application (MAA) for peginesatide solution for injection, which was intended to be used for treatment of symptomatic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 postmarketing 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.
About Takeda Development Centre Europe Ltd.
Based in London, England, Takeda Development Centre Europe Ltd., (TDC Europe), is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TDC Europe seeks to bring innovative products to people through a pipeline that includes compounds in development for diabetes, cardiovascular disease, neurology, oncology and other conditions. To learn more about the company, visit www.tdceurope.euAbout Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
SOURCE: Takeda Pharmaceutical Co
Post Views: 199
