While Actos is being plagued by its link to numerous life-threatening ailments, its heir may be facing guilt by association.
Takeda Pharmaceutical’s patent on pioglitazone (the active ingredient in Actos) is due to run out this August. The company will soon be facing competition from generic pioglitazone manufacturers. Because of this, the company is hoping to acquire FDA approval for its next generation of diabetes drug as soon as possible.
The drug has been rejected twice. It was first denied in 2009 because the FDA wanted more information on its heart risks. The reasons behind last week’s rejection are still unclear, but it may have something to do with the FDA lacking faith in alogliptin, the new drug’s active ingredient.