Marizev (omarigliptin) approved in Japan for type 2 diabetes- Merck
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved Marizev (omarigliptin) 25 mg and 12.5 mg tablets, from Merck. This is an oral, once-weekly DPP-4 inhibitor indicated for the treatment of adults with type 2 diabetes. Japan is the first country to have approved omarigliptin.
The approval in Japan is based on Phase III trials of Japanese patients. The worldwide clinical development program for omarigliptin, O-QWEST, includes 10 Phase III clinical trials involving approximately 8,000 patients with type 2 diabetes. Merck plans to submit omarigliptin for regulatory approval in the United States by the end of 2015. Other worldwide regulatory submissions will follow.
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