Takeda gets EMEA approval for combination treatment for Type 2 diabetes

Published: 20-Dec-2006
Regulatory Research & Development


Takeda Global Research & Development Centre Europe (TGRD Europe) has received a positive opinion from the European Medicines Agency (EMEA), for the new indication for ACTOS (pioglitazone HCl).

The new indication is a combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin and for whom metformin is inappropriate because of contraindications or intolerance.

At the same time, the CHMP adopted the removal of the contraindication for use of ACTOS in combination with insulin.

"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, 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."

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

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