News Feature | December 2, 2014

Merck Files Omarigliptin Application For T2D In Japan

By Estel Grace Masangkay

Merck reported that it has filed a New Drug Application (NDA) for its investigational drug omarigliptin as treatment for patients with Type 2 diabetes in Japan.

Omarigliptin is a DPP-4 inhibitor being developed as a once-weekly treatment for T2D. The company said its regulatory filing with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is supported by results from a Phase 3 study of the drug conducted in Japan. Merck’s clinical development program for omarigliptin also includes several other late-stage trials that enrolled an estimated 7,500 patients with T2D. Results show that omarigliptin demonstrated comparable efficacy to sitagliptin, another drug developed by Merck as potential combination treatment with Pfizer's investigational T2D drug, ertugliflozin. The company presented the results at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna.

Around 13.5 percent of the Japanese population is afflicted with Type 2 diabetes. The disease is projected to be the seventh leading killer in 2030 around the world. Peter Stein, VP of clinical research, diabetes and endocrinology, at Merck Research Laboratories, said, “Merck is committed to helping patients with type 2 diabetes and we are excited about the submission of the new drug application for omarigliptin in Japan. More than six million adults in Japan have type 2 diabetes. If approved in Japan, omarigliptin could provide an important new treatment option to help these patients attain their blood sugar goals.”

Merck has been actively developing partnerships to strengthen its diabetes treatment program and pipeline. Last year, Merck linked with Pfizer to develop the latter’s Type 2 diabetes drug ertugliflozin, an oral sodium glucose cotransporter (SGLT2) inhibitor that works to excrete excess glucose in urine. The company also inked a deal with Samsung Bioepis earlier this year for its insulin glargine candidate MK-1293, which is intended for both Type 1 and Type 2 diabetes.