Japan's Takeda Pharmaceutical has submitted a second post-marketing study to regulators in the United States, Europe and Japan that it says shows no increased risk of bladder cancer in patients treated with Actos (pioglitazone) in a key milestone following its April decision to settle thousands of lawsuits related to the diabetes drug.
Takeda said in a press release that the multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone-containing medicines showed no association between the use of pioglitazone and the risk of bladder cancer.
Takeda has steadfastly insisted Actos was not a cause of bladder cancer in patients taking the Type 2 diabetes drug, but earlier this year decided to reach a grand settlement with thousands of patients in the U.S. after it lost lawsuits in several courts.
The settlement, as much as $2.4 billion, led the company to report its first net loss since it listed on the Tokyo Stock Exchange in 1949.
The settlement covered about 8,000 lawsuits at the rate of $287,000 per case.
Takeda noted in the release that the second study was consistent with a 10-year prospective cohort study conducted by the University of Pennsylvania and the Division of Research at Kaiser Permanente Northern California (KPNC), which demonstrated no increased risk of bladder cancer among patients exposed to pioglitazone.
"Additionally, both studies found no association between the risk of bladder cancer and cumulative dose of pioglitazone, or duration of pioglitazone exposure," Takeda said in the release.
The second study was completed as part of a post-marketing request from the Committee for Medicinal Products for Human Use, or 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)," Takeda said in the release.
"The data will be shared with additional regulatory authorities in accordance with local requirements around the world."
Actos once accounted for 27% of the company's revenue at peak sales above $4 billion.
But a 2015 Louisiana trial resulting in a $9 billion verdict against Takeda and marketing partner Eli Lilly ($LLY), later reduced by more than 99%, apparently led new CEO Christophe Weber, who took over the post formally on April 1, to conclude that a settlement was in the company best interest.
- here's the release