Takeda Submits New Drug Application In The U.S. For Investigational Type 2 Diabetes Therapy, Fixed-Dose Combination Alogliptin/Metformin
OSAKA, Japan and DEERFIELD, Ill., Nov. 23, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet. The FDA is expected to review the NDA submission within the next ten months, the standard review period for a new application.
"This NDA submission further extends Takeda's commitment to offering patients with type 2 diabetes a range of therapeutic options to help them manage their condition," noted Thomas Strack, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc., U.S. "The worldwide incidence of type 2 diabetes continues to expand at a rapid rate and we continue our research into additional medications to treat these patients."
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 medication that acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
Common adverse reactions reported in greater than or equal to 5 percent of patients treated with co-administration of alogliptin with metformin were: upper respiratory tract infection, nasopharyngitis, creatinine renal clearance decreased, diarrhea, headache, hypertension, and urinary tract infection.
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