Takeda’s Actos Drug Needs New Cancer-Risk Warning, EMA Says

Takeda Pharmaceutical Co.’s Actos diabetes drug may be kept on the market with new warnings, the European Medicines Agency said after reviewing research showing the drug carried a slightly increased risk of bladder cancer.

The benefits of pioglitazone, the active ingredient in Actos and other diabetes treatments, outweigh its risks “in a limited population of Type 2 diabetics,” the London-based agency’s Committee for Medicinal Products for Human Use said today in a statement on its website.

“These medicines remain a valid treatment option for certain patients with type 2 diabetes,” though there is a small increased risk of bladder cancer, the EMA said. The risk could be reduced by “appropriate patient selection and exclusion,” including regular reviews of how well the drug is working for individual patients, the agency said.

The EMA’s backing supports the decision made by the U.S. Food and Drug Administration that Actos wasn’t linked to an overall increased cancer risk in all patients who took it. Actos had sales of 387.9 billion yen ($5 billion) in the last fiscal year, accounting for 27 percent of revenue. That makes it the best-selling product for Osaka, Japan-based Takeda, Asia’s largest drugmaker.

EMA Review

The EMA has been reviewing the possible cancer risk of Actos and other medicines containing pioglitazone since March. France’s drug regulator in June said it would pull Actos from the market, and its counterpart in Germany recommended that the EMA suspend marketing approval for the diabetes medicine throughout the 27-nation European Union.

Takeda shares rose 0.1 percent to 3,715 yen in Tokyo trading today before the announcement, while the benchmark Topix Index was little changed.

Actos became the world’s biggest-selling diabetes drug after a 2007 study linked rival pill Avandia, sold by London- based GlaxoSmithKline Plc (GSK), to a higher chance of heart attacks. The EMA in September suspended sales of Avandia, while the U.S. regulator decided the medicine could continue to be sold with new warnings.

The results of a French study showed the diabetes medicine carried a slightly increased risk of bladder cancer, prompting the regulator to order its withdrawal on June 9. The epidemiological study, conducted by the French health insurer, followed patients taking the medicine between 2006 and 2009.

A five-year analysis from a decade-long company-sponsored study of Takeda’s Actos showed an increased risk of bladder cancer in patients who took the drug for the longest periods of time, and at the highest cumulative doses, the FDA said on June 15. The medicine wasn’t linked to an overall increased cancer risk in all patients who took it, the agency said. The FDA had required the study under new guidelines for diabetes drug approvals.

Takeda has said it is working with the FDA to update the drug’s prescribing information.

Actos had shown a potential risk of bladder cancer in earlier studies on rats and humans. Takeda won FDA approval of the treatment in 1999 and agreed to conduct the 10-year study to assess that risk.

To contact the reporter on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net

To contact the editors responsible for this story: Jason Gale at j.gale@bloomberg.net; Phil Serafino at pserafino@bloomberg.net