MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan


September 28, 2015 6:30 am ET

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.

About Merck

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,
and connect with us on Twitter,
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1 IDF Diabetes Atlas. 6th Edition. Available at:

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