The Food and Drug Administration has denied approval to the successor of the type II diabetes drug Actos. The agency cited a need for additional data from the drug’s manufacturer, Takeda Pharmaceuticals, amid concerns about the possible side effects of the drug, known as alogliptin.
Takeda originally submitted alogliptin for FDA approval in 2007, but failed to win approval when the agency asked for additional information about the cardiovascular risks associated with the drug. The agency again denied the Actos successor in 2009, asking for statistics from the drug’s use in other countries.
The FDA also expressed concerns about the Takeda’s previous diabetes drug, Actos, which has been found to increase the risk of bladder cancer and cardiovascular problems. Patients who used Actos for more than one year were 40% more likely to develop bladder cancer than patients using other type II diabetes medication.