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news.Takeda Global R&D Center has submitted a new drug application to the FDA for alogliptin for the treatment of type 2 diabetes.
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Alogliptin (SYR-322) was designed to selectively inhibit dipeptidyl peptidase-4 (DPP-4) taken orally once daily.
The new drug application (NDA) submission was supported by six Phase III clinical trials involving over 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs) and insulin.
Yasuchika Hasegawa, president of Takeda, said: “The NDA submission for alogliptin is a significant milestone for Takeda, as it has the potential to position us as one of the global leaders in diabetes treatment. Takeda’s continued growth, now and in the future, will be based on our ability to focus and have success in this therapeutic area. Our hope is that alogliptin will become an important treatment option for patients with type 2 diabetes and the healthcare providers who treat them.”