Actos-Makers Seek FDA Approval for New Drug

Takeda Pharmaceuticals is currently going through the FDA approval process for a new type 2 diabetes drug, alogliptin. If Takeda is successful, the proposed new drug would be available both by itself and in combination with Actos.

Takeda initially submitted the new medication for FDA approval in 2007 but the approval was rejected by the FDA after the existing data on the drug was deemed insufficient. The Japanese pharmaceutical giant resubmitted a pair of New Drug Applications for alogliptin and the alogliptin/Actos combination to the FDA in July of 2009. The FDA has set the date to decide for January 25th, 2011.

Takeda’s optimism about the new drug may be tempered by an FDA safety alert that noted the drug may be related to an increased risk of cancer. The approval of the new combination pill comes at a bad time for Takeda Pharmaceuticals which is currently facing numerous lawsuits stemming from issues raised in the FDA alert.