FDA declines to approve Takeda diabetes drug
DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.
Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.
A complete response letter means that the FDA has finished reviewing a drug approval application, but questions remain that preclude approval. In this case, the agency requested additional data about the drugs, which Takeda said it would supply from clinical trials.