Actos News

Takeda's New Diabetes Drug Not Approved by FDA
Wednesday, April 25, 2012

The U.S. Food and Drug Administration (FDA) has denied Takeda Pharmaceuticals clearance to sell their new diabetes drug called Aloglipton in the U.S. According to a Takeda press release, the company received a "complete response letter" from the FDA, which stated that the agency could not approve aloglipton (or the treatment combination consisting of aloglipton and pioglitazone) without more data on how the drugs have performed in countries where they are approved and available. Aloglipton, a DPP-4 inhibitor in the same family of drugs as Januvia, Onglyza and Trajenta, is approved in Japan under the brand name Nesina. 

Takeda is currently seeking a new diabetes treatment because they will be losing their patent on Actos (pioglitazone) in four months, and the drug will be on the open generic market. A link between the Actos and bladder cancer has sparked controversy in the international community, with both France and Germany suspending the use of pioglitazone-containing drugs like Actos from their markets in 2011. The Actos bladder cancer risk also prompted the U.S. to add a warning to the drug's label informing patients about the risk. Takeda is expected to face thousands of Actos bladder cancer lawsuits in the U.S. for alleged negligence, improper research and attempt at concealing the dangers associated with the diabetes drug.

 According to Bloomberg, he FDA previously rejected aloglipton in 2009, stating that Takeda's clinical data was not sufficient for approval in the U.S.