Takeda pays $2.7 billion to settle Actos lawsuits
pharmafile | May 1, 2015 | News story | Sales and Marketing | Actos, FDA, Takeda, bladder, lilly, pioglitazone, type 2
Takeda has agreed to pay $2.7 billion to finally settle thousands of US lawsuits claiming its diabetes drug Actos can lead to cancer.
Over 8,000 suits accuse the Japanese firm and Eli Lilly, who co-produce the drug, of covering up concerns that Actos (pioglitazone) can cause or worsen heart failure, plus slightly increase the risk of bladder cancer. One trial that found in favour of the plaintiff resulted in the two companies being ordered to pay $9 billion in damages, although this was later reduced to $36.8 million.
However Takeda contends that it has done nothing wrong. It its statement the firm says that it believes the claims made in the litigation are ‘without merit’, and that it does not admit liability.
“Takeda believes the company acted responsibly with regard to Actos, and that it has a positive benefit/risk profile for the treatment of type 2 diabetes,” it adds.
“The decision to settle does not change the firm’s continued commitment to the drug. Takeda stands behind the substantial data that confirm a positive benefit/risk profile for Actos, which includes more than 14 years of clinical and patient experience with the product.”
Studies on the matter have been conflicting. In 2011 the FDA announced that using the treatment for more than one year could indeed be associated with an increased risk of bladder cancer, after a conducting a safety review into the medicine.
Results from patients in France and Germany also found an increased risk of bladder cancer in patients who were prescribed Actos for two or more years, and the drug was subsequently banned in the countries.
However, a more recent meta-analysis that looked at data from 1,000,000 patients found no link between the medicine and cancer.
Takeda says that it expects the settlement to resolve the ‘vast majority’ of Actos lawsuits, and that overall it will reduce financial uncertainties for the company despite the charge against earnings.
George Underwood
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