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news.Takeda Pharmaceutical has submitted a New Drug Application (NDA) to the US FDA for the fixed-dose investigational type 2 diabetes combination therapy which combines alogliptin with metformin in a single tablet.
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Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) which is being evaluated in the US to treat type 2 diabetes as an adjunct to diet and exercise.
Metformin is diabetes medication that acts by reducing the amount of glucose produced by the liver.
Takeda Global Research & Development Center vice president Thomas Strack said the submission reflects the company’s commitment to offer patients with type 2 diabetes a range of therapeutic options.
"The worldwide incidence of type 2 diabetes continues to expand at an alarming rate and we continue our research into additional medications to treat these patients," Strack added.
The FDA’s standard review period for a new application is ten months.