Takeda Pharmaceutical Co has decided not to go ahead with a filing in Europe of a longer-lasting version of its diabetes combination treatment.

The Japanese drugmaker has withdrawn a European marketing authorisation application for a prolonged-release formulation of Competact, a fixed-dose combination of Takeda’s blockbuster Actos (pioglitazone) and metformin hydrochloride. The decision to withdraw the MAA and indeed discontinue development was made following discussions with the European Medicines Agency’s Committee for Medicinal Products for Human Use 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”.

The immediate-release formulation of Competact which has a twice daily dosing, was approved in Europe in July 2006, “and is a well established treatment option”, Takeda says. It competes with GlaxoSmithKline’s Avandamet ((rosiglitazone/metformin).

It is a blow for Takeda which has been looking to reduce its reliance on Actos. Generic versions of the latter will hit the US market in August 2012