KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved MARIZEV®(omarigliptin) 25 mg and 12.5 mg tablets, 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.
"More than 6 million adults in Japan have type 2 diabetes1 and many still struggle to control their blood sugar levels," said Tony Alvarez, president, MSD in Japan. "The approval of MARIZEV in Japan demonstrates our long-term commitment to diabetes and leadership in the DPP-4 inhibitor class. We believe MARIZEV offers an important option for people in Japan to manage their type 2 diabetes, particularly for those who prefer once-weekly dosing."
The approval of MARIZEV in Japan is based on Phase 3 trials of Japanese patients. The worldwide clinical development program for omarigliptin, O-QWEST (Omarigliptin Q Weekly Efficacy and Safety in Type 2 Diabetes), includes 10 Phase 3 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. The trademark for omarigliptin in other countries has not yet been announced.
Merck commitment to diabetes
At Merck, we are committed to improving type 2 diabetes care through scientific advancement and innovation for the millions of people living with diabetes every day. We strive to deliver a broad range of treatments and educational tools for patients and healthcare providers and are applying significant resources and capabilities with a continued focus on research and development.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
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1 IDF Diabetes Atlas. 6th Edition. Available at: https://www.idf.org/membership/wp/japan