Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Takeda Pharmaceutical Company has announced that its wholly owned subsidiary, Takeda Global R&D Center has submitted a new drug application to the FDA for marketing approval of Alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.
Subscribe to our email newsletter
The new drug application (NDA) submission was supported by two Phase III clinical trials, involving more than 2,000 patients worldwide. The studies assessed the efficacy and safety of this therapy for the treatment of patients with type 2 diabetes not achieving glycemic targets with diet and exercise alone, or for patients uncontrolled on metformin.
Study results showed that Alogliptin /Actos produced significant improvements in glycemic control and measures of insulin resistance and beta-cell function. In clinical trials, alogliptin/Actos was generally well-tolerated.
Alogliptin was discovered by Takeda’s wholly owned subsidiary, Takeda San Diego, and is a member of the DPP-4 inhibitors class, which are newer oral agents for the treatment of type 2 diabetes.
Actos is a thiazolidinedione that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, the company said.
Yasuchika Hasegawa, president of Takeda, said: “Alogliptin/Actos, if approved, will be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor and a thiazolidinedione. Given the increased global incidence of type 2 diabetes and the need for new treatment options, we will strive to provide alogliptin/Actos, as a potentially important treatment option, to patients and healthcare providers.”