Prior CHMP positive benefit-risk for pioglitazone confirmed; EMA starts NSAIDS review

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has clarified its opinion on pioglitazone-containing anti-diabetes medicines and the risk of bladder cancer. The Committee confirmed its previous opinion, introducing some clarifications for transparency and consistency purposes: pioglitazone remains a valid treatment option for certain patients with type 2 diabetes, when certain other treatments (metformin) have not been suitable or have failed to work adequately. The new warnings and contraindications recommended in July 2011 remain in place.

Earlier this year, the CHMP reviewed its opinion on pioglitazone, the active ingredient of Japan’s largest drugmaker Takeda’s (TYO: 4502) blockbuster Actos which in the last fiscal year generated sales of $4.8 billion, on the request of the Commission as it failed to gain endorsement in the Standing Committee on Medicinal Products for Human Use (The Pharma Letter July 22). This body, which consists of representatives of all EU Member States, has to be consulted before the European Commission transforms the Agency's opinion into legally enforceable decisions.

In July 2011 the CHMP had finalized a review of pioglitazone and the risk of bladder cancer. The Committee found that there was a small increased risk of bladder cancer. However, because the Committee considered that there are a limited number of patients who cannot be adequately treated by other treatments, it concluded that pioglitazone should remain available as a treatment option, but that prescribers should carefully select patients and monitor their response to treatment.