Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Jul 31 2015

Second Study Indicates No Increased Risk of Bladder Cancer in Patients Treated With Pioglitazone, Further Reinforcing the Positive Benefit/Risk Profile

Takeda Pharmaceutical Company Limited (“Takeda”) today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including ACTOS (pioglitazone HCI) with up to 10 years of follow-up. Findings demonstrate that there is no association between the use of pioglitazone and the risk of bladder cancer, (hazard ratio [HR] 0.99 [95% CI: 0.75, 1.30]). These results are consistent with those of a 10-year, prospective cohort study, conducted by the University of Pennsylvania (U. of Penn.) and Division of Research at Kaiser Permanente Northern California (KPNC), which demonstrated no increased risk of bladder cancer among patients ever exposed to pioglitazone ([HR] 1.06 [95% CI 0.89-1.26]). Additionally, both studies found no association between the risk of bladder cancer and cumulative dose of pioglitazone, or duration of pioglitazone exposure.

“ACTOS is an important treatment option for patients with Type 2 diabetes. These data further reinforce the positive benefit/risk profile for ACTOS,” said Alfonso Perez, MD, vice president, clinical research, Takeda. “These long-term studies underscore Takeda’s commitment to ensuring physicians have the best available information to make treatment decisions.”

The data from the Pan European Multi-Database Bladder Cancer Risk Characterization Study also shows a mortality decrease with ever use of pioglitazone (adjusted HR 0.67 [95% CI: 0.64, 0.70]). This study was completed as part of the post-marketing request from the Committee for Medicinal Products for Human Use (CHMP). In addition to the European Medicines Agency (EMA), the results from the Pan European study were also submitted to the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA). The data will be shared with additional regulatory authorities in accordance with local requirements around the world.

“Patient safety remains a top priority for Takeda,” said Perez. “Throughout a product’s lifecycle we continue to monitor and conduct additional research to further our knowledge. This milestone is an important example of Takeda’s commitment to conducting further research and sharing the outcomes with regulatory agencies, physicians, and others.”