MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan
September 28 2015 - 7:30AM
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.
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, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
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References
1 IDF Diabetes Atlas. 6th Edition. Available at:
https://www.idf.org/membership/wp/japan
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