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As sales of the brand-name version of the diabetes drug Actos continue fall amid mounting injury lawsuits and recent generic competition, Takeda Pharmaceuticals has launched a trio of new drugs meant to shore up its diabetes medication revenues.
The FDA issued approval for the alogliptin-based drug Nesina and two related combination drugs for the treatment of type 2 diabetes on January 25.
Takeda’s blockbuster drug Actos was once the top-selling diabetes drug on the market, but since concerns surfaced in late 2010 about an increased risk of bladder cancer from side effects of Actos, sales have been steadily falling. Generic equivalents were also introduced in August 2012, which have further eaten into sales for the diabetes treatment.
Alogliptin stimulates the release of insulin after a meal, lowering blood sugar levels. Takeda claims the drug is safe, following several clinical trials involving about 8,500 diabetes patients. However, the FDA is requiring five Nesina postmarketing studies that will look for heart problems, liver damage, pancreatitis, hypersensitivity and possible pediatric uses.
Many analysts view the new drugs as an effort by Takeda Pharmaceuticals to make up for the lost revenues caused by Actos. In addition to Nesina, Takeda will also roll out a combination of Actos and Nesina, which will be sold under the name Oseni, and a combination of Nesina with metformin, which will be sold as Kazano.
Takeda Faces Mounting Actos Lawsuits
In addition to declining sales for the Actos franchise, Takeda Pharmaceuticals also faces a mounting number of product liability lawsuits over Actos, which have been brought on behalf of former users who allege the drug maker failed to adequately research the side effects of the medication or warn about the risk of tumors after long-term use.
The FDA launched a safety review of Actos in September 2010, after receiving the early data from this on-going study found an increased incidence of bladder cancer among users of Actos.
The following summer, a study conducted by French insurers further increased concerns within the medical community about an increased risk of bladder cancer diagnosis following Actos use, leading to a decision to remove Actos from the market in France.
In the United States, the FDA added new warning language to the Actos warning label in August 2011, indicating that use of the drug for more than one year may increase the risk of bladder cancer.
More than 1,000 Actos bladder cancer lawsuits have been filed in state and federal courts throughout the United States, and many expect that there may eventually be more than 10,000 complaints filed on behalf of former users of the diabetes drug diagnosed with bladder cancer.
The first Actos trial is expected to begin next month in California state court, involving a lawsuit brought by Jack Cooper. The case will reach a jury nearly two years before the first federal trial dates are expected to begin, with bellwether cases set for November 2014 and January 2015.