Merck & Co submits first regulatory filing for omarigliptin, in Japan

25 November 2014

US pharma giant Merck & Co (NYSE:MRK) has submitted a new drug application 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).

The company notes that Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development program that includes nine Phase III clinical trials involving around 7,500 patients with type 2 diabetes in support of planned regulatory filings.

More than 6 million type 2 diabetes patients in Japan

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