Withdrawal from the Market of Pioglitazone-Containing Products:Actos and Competact in France
European Medicines Agency Continues Review of Marketing Authorizations for Products Containing Pioglitazone
Osaka, Japan, July 11, 2011 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its wholly owned subsidiary, Laboratoires Takeda (Puteaux, France), is today withdrawing pioglitazone-containing products; Actos® and Competact® in France, at the request of AFSSAPS, the French health regulatory authority, following their decision to suspend the use of pioglitazone containing products for the treatment of type 2 diabetes.
Laboratoires Takeda is working with French regulatory authorities to implement the withdrawal. The decision to suspend the two products was taken on the basis of a small increased risk of bladder cancer in patients treated with pioglitazone observed in a French database study (CNAMTS) independently conducted by French authorities.
A pan-European review of pioglitazone (an “Article 20 Referral Procedure”) started in March 2011 and Takeda is fully cooperating with the EMA in the Article 20 review. Takeda was notified on June 23, 2011 (European time) that, the review of pioglitazone-containing medicines by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is on-going, and also that the CHMP will discuss the benefit / risk of these medicines at its next meeting in July 2011 and then give an opinion. To date the EMA has not concluded any recommendations for a change of label to pioglitazone-containing products nor has it recommended withdrawal in any European member states. The European Commission granted marketing authorizations for Actos® and Competact® valid throughout the European Union on October 13, 2000 and July 28, 2006 respectively.
Takeda is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes. We continuously monitor the safety and tolerability of all of our products and will continue to work with the EMA and other individual regulatory bodies to share and review all available data, and to determine appropriate next steps.
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About 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 patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
Contacts Japan: Europe: U.S.:
Seizo Masuda Rob Gallo Elissa J. Johnsen
Takeda Pharmaceutical Company Ltd. Takeda Pharmaceuticals Europe Ltd. Takeda Pharmaceuticals North America, Inc.
T: +81- 3- 3278- 2037
T: +44- 203- 116- 8829
M: +1- (312)- 285- 3203
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Posted: July 2011
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