According to an announcement by Takeda Pharmaceutical Company Limited earlier today, two New Drug Applications (NDAs) were resubmitted to the FDA by Takeda Global Research & Development Center. The NDAs were for Alogliptin and a fixed-dose therapy of alogliptin/pioglitazone, which is a single tablet combination of alogliptin with pioglitazone.
Over the next 6 months, the resubmissions will be reviewed by the FDA. As an adjunct to diet and exercise for the treatment of type 2 diabetes, pioglitazone was approved in 1999; similarly, the selective dipeptidyl peptidase IV inhibitor (DPP-4i) – alogliptin – is currently under investigation in the US. Alogliptin is discovered by Takeda San Diego, Inc., and is designed to impede the inactivation of 2 incretin hormones that regulate blood glucose levels: GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).
David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center said:”We believe interim results from a cardiovascular outcomes trial satisfy the FDA’s cardiovascular safety requirements to allow the Agency to complete its review of our NDA, and further support the product profile of alogliptin. If approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione in a single tablet.”
Interim results from the cardiovascular outcomes trial EXAMINE (EX amination of C A rdiovascular Outco M es: Aloglipt IN vs. Standard of Car E in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) have been included in the NDA resubmissions upon request by the FDA in order fulfill the criteria in “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” outlined in the December 2008. Further to evaluating standard of care vs standard of care alone and a recent acute coronary syndrome, this randomized, double-blind, placebo-controlled outcomes study continues to assess cardiovascular endpoints in patients with type 2 diabetes after treatment with alogliptin (ACS). The EXAMINE study was designed to comply with the Guidance and final study results are expected in 2014.
Robert Spanheimer, M.D., vice president, medical and scientific affairs, Takeda Pharmaceuticals North America said: “The NDA resubmissions mark a significant milestone for Takeda in the U.S., underscoring our deeply held commitment to providing therapeutic options for patients living with type 2 diabetes. We are confident in the data available for alogliptin, and look forward to building upon our global expertise in the diabetes therapeutic area.”