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Pioglitazone post-marketing commitment, complete safety data submitted
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The post-marketing commitment for the thiazolidinedione pioglitazone, developed by Takeda to treat type 2 diabetes, is complete following a 10-year epidemiology study demonstrating drug safety, according to a statement released by the pharmaceutical company.
Researchers at the University of Pennsylvania and Kaiser Permanente Northern California, found no significant increased risk of bladder cancer among patients ever exposed to the pioglitazone (Actos, Takeda), according to the statement.
Takeda announced submissions of data to regulatory authorities including the United States Food and Drug Administration, the European Medicines Agency and the Japanese Ministry of Health, Labor and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency for pioglitazone containing medicines.
The findings overturn those from a 5-year interim analysis on the therapy published in Diabetes Care that showed a statistically significant increased risk for bladder cancer among patients who used pioglitazone for 2 or more years; the 10-year results will be submitted for publication in 2014, according to the statement.
Launched in 1999 as an approved treatment for adults in addition to diet and exercise to improve glycemic control, the thiazolidinedione (TZD) has been tested in clinical trials involving more than 27,000 participants, according to the statement. Benefits have outweighed the risks, which have been communicated on product labeling, according to the statement.
“The results of the study provide reassurance with regard to the use of pioglitazone and the risk of bladder cancer and further support the positive benefit risk profile of the product,” Thomas Harris, head of global regulatory affairs at Takeda, said in the release.
For More Information: Lewis JD. Diabetes Care. 2011;10.2337/dc10-1068.