Takeda Withdraws European Marketing Authorization Application For Type 2 Diabetes Drug

March 19, 2010

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Takeda Pharmaceutical Company Limited announced today that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) Ltd.  withdrew a European Marketing Authorization Application (MAA) for Competact®, a prolonged-release formulation of its combination treatment for type 2 diabetes. Takeda also decided to discontinue the development of the prolonged-release formulation in Europe.
The decisions were made following discussions with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) that they were unlikely to adopt a formal positive opinion as they required additional data to confirm the long-term efficacy of the prolonged release metformin component of the tablet.
CHMP’s comments relate only to the Competact® prolonged-released formulation (once daily dosing).

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