Takeda Withdraws European Marketing Authorization Application For Type 2 Diabetes Drug

March 19, 2010

Category: , | Tags:

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).

Add a comment

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>