Takeda Pharmaceutical Company Limited announced that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) Ltd. has withdrawn a European Marketing Authorisation Application (MAA) for a prolonged-release formulation of its combination treatment for type-2 diabetes, Competact; a fixed-dose combination tablet of pioglitazone hydrochloride with immediate release metformin hydrochloride. After reviewing its options Takeda has also decided to discontinue the development of the prolonged-release formulation in Europe.
The decision to withdraw the MAA and discontinue development was 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) and not to Competact (immediate-release formulation, twice daily dosing), which was approved in the EU via the Centralised Procedure in July 2006, and is a well established treatment option for patients with type-2 diabetes. Competact continues to be available in most European countries and is not impacted by this decision.
Takeda is the originator of thiazolidinedione derivatives (TZDs) with the development of Actos (pioglitazone), which directly targets insulin resistance.