EC backs continued use of pioglitazone drugs for diabetes

Japan’s largest drugmaker, Takeda Pharmaceutical (TYO 4502) said yesterday that  the European Commission has adopted the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) opinion as recommended last year (The Pharma Letter October 24, 2011), which included label changes and clarification on the product indications for pioglitazone-containing medicines.

This concludes the European review which was initiated at the request of the European Commission in March 2011 and the label changes will now be incorporated within the Marketing Authorization of pioglitazone containing medicines, most notably Takeda’s blockbuster drug Actos, which generated sales of $4.8 billion in the last full fiscal year.

In July 2011, following a review under Article 20 of Regulation (EC) No. 726/2004, the CHMP concluded that pioglitazone-containing medicines remain a valid treatment option for certain patients with type 2 diabetes. While a small increased potential risk of bladder cancer has been associated in patients taking these medicines, the CHMP concluded that this risk could be reduced by appropriate patient selection and exclusion, updated contraindications and warnings in the product labels, and periodic review of the efficacy and safety of the patient’s treatment. In October 2011, the CHMP re-confirmed the positive benefit-risk balance of pioglitazone in the context of second and third line treatment. Furthermore additional clarification was also included for physicians on the correct treatment setting for pioglitazone, namely that pioglitazone remains a valid treatment option for certain patients with type 2 diabetes, specifically when metformin has not been suitable or has failed to work adequately.