Takeda Submits NDA for Type 2 Diabetes Therapy
Takeda submitted a New Drug Application to the FDA for the fixed-dose combination therapy alogliptin/metformin.
Takeda Pharmaceutical announced Wednesday that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., had submitted a New Drug Application (NDA) to the FDA for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet.
Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the U.S. for the treatment of type 2 diabetes as an adjunct to diet and exercise. Discovered by Takeda San Diego, Inc., alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in regulating blood glucose levels.
Metformin is a widely used diabetes m
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