Skip main navigation

Newsroom
Newsroom

Home > Newsroom > 2006 > Positive Opinion from European Regulatory Authorities for combination use of

Skip side navigation

Main contents starts here

December 20, 2006

Takeda Pharmaceutical Company Limited

Positive Opinion from European Regulatory Authorities for combination use of Actos®(pioglitazone HCl) with Insulin for Type 2 Diabetes

Osaka, Japan, December 20, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on December 14, 2006, its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") received positive opinion from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA"), recommending to grant the new indication for ACTOS® (pioglitazone HCl).

The new indication is "combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance." At the same time, the CHMP adopted the removal of the ontraindication for use of ACTOS in combination with insulin. Detailed conditions for the use of this product will be available after the variation to the marketing authorisation has been granted by the European Commission.

"For the treatment of patients with type 2 diabetes, it is common that physicians need to use combinations of products in order to maintain glycaemic control over time", said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. "The new indication for use of Actos in combination with insulin, once it is approved, will provide a further prescribing option for the physician, and help patients control their blood glucose effectively."

Takeda is the originator of thiazolidinedione derivatives and ACTOS is a member of the thiazolidinedione class of "insulin-sensitizing" agents, and it directly targets insulin resistance.

# # #

Page Top