FDA Rejects New Diabetes Drug with Actos
Two new Takeda Pharmaceuticals diabetes drugs which contain a new treatment as well as Actos have been rejected by the FDA. Actos is a diabetes drug currently in use which has been linked to a heightened incidence of bladder cancer.
On April 25, Takeda released a press release stating that the company had received a “complete response letter” from the FDA. This letter stated that the regulatory agency cannot approve a new drug alogliptin and the combination of alogliptin and pioglitazone (Actos) without further data attesting to the safety of the drugs, which have already been approved in other countries.
Takeda hopes that the new diabetes treatment will be a replacement for Actos. Actos is Takeda’s flagship diabetes drug and it will lose patent protection in just a few months, allowing cheaper generic versions to enter the market as competitors.
Recent concerns have arisen about the heightened incidence of bladder cancer in Actos patients. This caused the addition of new warning labels on the drug in the United States, Canada, and Europe and also caused an Actos recall in France. A number of critics are also calling for a U.S. Actos recall.
More than one patient has filed a dangerous drug lawsuit against Takeda Pharmaceuticals, based on claims that the drug maker did not adequately warn of the danger of Actos bladder cancer and that they tried to conceal this risk from doctors and patients.
The new drugs are based on alogliptin, which has been approved in Japan under the name Nesina. This drug is a DPP-4 inhibitor, and is in the same family as Januvia, Onglyza, and Tragenta. Another newly proposed drug is a combination of alogliptin and Actos.
Takeda has stated that data from Nesina use in Japan and a number of ongoing studies will allow it to satisfactorily answer the FDA’s questions. Still, the company has been seeking approval of the drug since 2007. It was rejected in 2009, when the FDA stated that clinical data was not sufficient for U.S. approval. This stance has not changed almost three years later.
Contact an Actos Lawyer
If you were diagnosed with bladder cancer after taking Actos, you may be owed compensation for your damages. Learn more about your rights in a free legal consultation with a pharmaceutical product liability lawyer.