Takeda and Lilly will no doubt be breathing a huge sigh of relief after ten-year data from patients with type II diabetes taking Actos (pioglitazone) found no greater risk of bladder cancer from short-term exposure or long-term use.
The findings are a marked contrast to five-year data from an interim analysis, published in Diabetes Care at the time, which showed that significantly more patients taking the drug had developed the disease.
The Japanse drugmaker said it has now completed its post-marketing commitment to submit long-term data from the 10-year epidemiology study to regulators in the US, Europe and Japan.
Bob Ryder, Consultant in Diabetes, City Hospital, Birmingham, noted that the diabetes community is “pleased to see that there is no increased risk of bladder cancer with long-term use of pioglitazone”, adding that the drug “is a valuable treatment to have in our armory and therefore these results are reassuring for clinicians who prescribe the treatment for their patients”.
But Takeda and Eli Lilly are still facing punitive damages of a whopping $9 billion after failing to overturn a court ruling in April this year that they hid the potential cancer risks linked with Actos.
In the case, diabetes patient Terrence Allen, who developed bladder cancer after taking Actos, alleged that Takeda was aware of possible link with bladder cancer years before it warned of the risks, and during the case it reportedly came to light that the firm had dumped thousands of related emails and documents.
But both Lilly and Takeda said they will appeal the decision.