European Commission Adopts European Medicines Agency’s Opinion Confirming Pioglitazone-Containing Medicines Remain a Valid Treatment Option for Appropriate Type 2 Diabetes Patients
European Commission review is now concluded following the adoption of the
CHMP Opinion made in October 2011
Osaka, Japan and London, United Kingdom, 10th January 2012 -- Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the European Commission (EC) has adopted the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP) opinion as recommended in October 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.

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.

Takeda continues to remain confident in the therapeutic benefits of pioglitazone as an important treatment for type 2 diabetes, and remains committed to pioglitazone and pioglitazone-containing medications, and to the millions of people living with type 2 diabetes. The company will continue to make these products available so that patients can benefit from them.

Takeda recommends that any patients taking pioglitazone-containing medications consult their health care provider if they have any questions.

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