Takeda Pharmaceutical Company Limited (Takeda) announced that, on June 9, 2011 European time, its wholly owned subsidiary, Laboratoires Takeda (Puteau, France) was informed by AFSSAPS, French regulatory authorities, that AFSSAPS intends to suspend the use of pioglitazone containing products for the treatment of type 2 diabetes in France including Actos (pioglitazone hydrochloride) and Competact (pioglitazone hydrochloride and metformin hydrochloride). Namely, physicians can no longer prescribe products containing pioglitazone to new patients while it recommends that patients currently treated with pioglitazone do not stop their treatment and consult their physician to adapt their diabetes treatment.
The decision to suspend the two products was taken on the basis of a small increased risk with statistically significance of bladder cancer in patients treated with pioglitazone observed in a French database study (CNAMTS) independently conducted by French authorities.
The European Medicines Agency (EMA) also acknowledged in a statement on June 9, 2011 that: “While review of pioglitazone is ongoing the Committee for Medicinal Products for Human Use (CHMP) is not recommending any changes to the use of pioglitazone-containing medicines.”
Takeda notes that a pan-European review of pioglitazone (an “Article 20 Referral Procedure”) started in March 2011 and is ongoing within the EMA. Takeda is fully cooperating with the EMA in the Article 20 review and has provided all the available data on safety and efficacy of pioglitazone, which, as well as the results of the CNAMTS study, are expected to be taken into account by the CHMP meeting held 20-23 June upon conclusion of the Article 20 Procedure.
In the US, Takeda is working with appropriate regulatory agencies, and is currently supporting a ten-year epidemiological study, started in 2002 by the University of Pennsylvania and Kaiser Permanente Diabetes Registry, Northern California, investigating the questions raised about ACTOS and bladder cancer. In the interim analysis of this epidemiologic data, published in Diabetes Care April 2011, the primary endpoint showed that treatment with pioglitazone was not associated with a statistically significant increase in the incidence of bladder cancer. Takeda is committed to supporting this study through its conclusion at the end of 2012 and will report on the final results upon completion in 2013.
Patient safety is always the first priority for Takeda, thus, it is committed to continuously monitor the safety and tolerability of all the products marketed by its own, including those containing pioglitazone. Takeda is also committed to provide patients population, healthcare providers and all other stakeholders with the information on our products in a timely and appropriate fashion.
Takeda, a research-based global company with its main focus on pharmaceuticals. It is committed to strive towards better health for patients worldwide through leading innovation in medicine.