Takeda Global Research & Development Center, a wholly owned subsidiary of Takeda Pharmaceutical Limited, has submitted a new drug application (NDA) to the FDA for marketing approval of its alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.
Alogliptin (SYR-322) was discovered by 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, according to the Osaka, Japan-based company.
Takeda said its DPP-4 inhibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The incretins play a role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. Takeda is the originator of the thiazolidinedione (TZD) class of oral anti-diabetes medications. Actos(pioglitazone HCl) is a TZD that directly targets insulin resistance.
However, TZDs have recently come under scrutiny for the connection to heart failure.
“Alogliptin/Actos, if approved, will be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor and a TZD,” said Yasuchika Hasegawa, president of Takeda.
The company added that the NDA submission was supported by two phase 3 clinical trials, involving more than 2,000 patients globally.