Takeda granted EC marketing authorisation for Tandemact

Takeda Pharmaceutical has announced this week that its European subsidiary, Takeda Global Research & Development Centre Europe (TGRD Europe), was granted marketing authorisation from the European Commission for Tandemact.

Tandemact is a fixed combination tablet form of Actos (pioglitazone HCl) and glimepiride HCl that is orally administered once a day with food.

It is indicated for the treatment of type two diabetes mellitus in patients that have shown intolerance to metformin or have shown contraindication of metformin who are already receiving a combination pioglitazone and glimepiride treatment.

Dr Masaomi Miyamoto, general manager of pharmaceutical development at Takeda, said: “We are very pleased with this approval of Tandemact, which enables us to provide an additional treatment option for the patients with type two diabetes.”

He added that prescription with Tandemact could provide patients with a simpler combination treatment, as patients are often forced to control diabetes with the prescription of multiple medications.

In October 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued TRGD Europe a positive opinion on Tandemact following the company’s application in July 2005.

CHMP issued a positive opinion for a new indication of Actos in December 2006 and removed the contraindication of use of Actos with insulin.