Merck Submits NDA to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin for Type 2 Diabetes

Merck (MSD outside the US and Canada) has submitted a new drug application (NDA) for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

“Merck is committed to helping patients with type 2 diabetes and we are excited about the submission of the NDA for omarigliptin in Japan,” said Peter Stein, M.D., Vice President, clinical research, diabetes and endocrinology, Merck Research Laboratories.

“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.”

The NDA for omarigliptin is based on a comprehensive clinical development programme in Japan. The results from the first Phase III study of omarigliptin, conducted in Japan, were presented recently at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting.

Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development programme that includes nine Phase III clinical trials involving approximately 7500 patients with type 2 diabetes in support of planned regulatory filings.