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Takeda: No link between Actos and bladder cancer

Ten-year study backs safety of diabetes drug
Takeda pharma building

Researchers have published a 10-year study that shows there is no statistically significant increased risk of bladder cancer among people who take Takeda's diabetes drug Actos.

Concerns were raised several years ago about Actos' potential to increase the risk of bladder cancer, leading to the withdrawal of the drug in France and Germany and the launch of billions of dollars worth of lawsuits in the US.

As a result regulators in both the EU and the US launched safety reviews of the drug, which was launched onto the market in 1999 and is now available as a generic.

Both the FDA and the European Medicines Agency (EMA) determined that Actos was safe enough to remain on the market provided its label was updated to mention a slight increase in the risk of bladder cancer.

This decision was based on a five-year interim analysis of the study conducted by University of Pennsylvania and a Division of Research at Kaiser Permanente Northern California, which suggested a statistically significant increased risk of developing bladder cancer among patients who used Actos for two years or more.

However, the complete 10-year study does not back this assertion, according to Takeda, and the company will now submit the data to the FDA, the EMA and the Japanese Ministry of Health, Labour and Welfare.

“The completion of this long-term study is a milestone in the history of pioglitazone,” said Tom Harris, head, global regulatory affairs, Takeda. “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.”

Despite this data, Takeda and its partner Lilly still face a $9bn payout in the US following a lawsuit that claims officials at the company knew Actos was linked to bladder cancer and failed to properly warn patients and doctors before assessing the damages.

As reported by Bloomberg, Takeda is likely to appeal the decision. A Takeda spokesperson told the news agency: “We disagree with the ruling and await a ruling on our motion for a new trial. We continue to believe that binding legal precedent requires the judge to disregard the verdict in its entirety and grant a new trial.”

Article by
Thomas Meek

29th August 2014

From: Research, Sales, Regulatory

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