Takeda Pharmaceutical received more bad news last week when the FDA requested more information with regards to its new Type2 Diabetes Drug chemically knows as alogliptin and currently marketed in Japan as Nesina. Takeda had hoped to introduce alogliptin into the US as a replacement for its troubled Type2 Diabetes drug, Actos, before Actos goes generic in August and it now appearsthat release will not occur.
Takeda has seen a string of bad news with regards to Actos as a result of an increased risk of bladder cancer. In June of 2011 The FDA issued a warning regarding this risk while several European markets took it a step further, suspending the use of actos over these same concerns.
Global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010 alone and Takeda had hoped that alogliptin would help capture a part of that market.
This rejection of alogliptin’s approval marks the second time that the replacement drug has failed to gain approval in the United States. Given the dangers and risks associated with Actos, it is important that the F.D.A. continues to proceed only with caution before approving any replacement drug.
TorHoerman Law is leading the Cook County Actos litigation against Takeda Pharmaceutical and we will continue to monitor the investigation into the safety and efficacy of Actos and its replacement drug alogliptin.