Takeda Pharmaceutical Company Ltd has announced that on, its wholly owned subsidiary, Takeda Global Research & Development Centre Ltd. has 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 glycaemia control on insulin 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. Detailed conditions for the use of this product will be available after the European has granted the variation to the marketing authorisation 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 glycaemia control over time", said Masaomi Miyamoto, PhD, 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-sensitising" agents, and it directly targets insulin resistance.