Oral med approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for type 2 treatment.
Japan has recently approved Omarigliptin (Marizev) a potent, once-weekly, oral dipeptidyl peptidase-4 (DPP-4) inhibitor developed for the treatment of type 2 diabetes. It is available in 25mg and 12.5mg tablets. It is the second once-weekly approved DPP-4 inhibitor in Japan. The first being trelagliptin (Zafatek), approved in March, although neither of these agents has been approved elsewhere in the world.
A randomized, double-blinded, parallel-group, active, placebo-controlled study in monotherapy for Japanese patients with type 2 diabetes in which a 25mg/week omarigliptin was compared with the standard 50mg/day sitagliptin (Januvia). A total of 414 patients who were inadequately controlled were followed for 24 weeks.
The endpoint for patients receiving omarigliptin was a significantly greater mean reduction in HbA1c from baseline in comparison to patients on placebo (0.66% vs 0.13%, P<0.001). There were similar endpoint results in patients receiving once-weekly omarigliptin and daily sitagliptin. (0.66% vs 0.65%). Besides its ability to significantly lower HbA1c levels, Omarigliptin also showed a significant reduction in 2-hour postmeal glucose and fasting plasma glucose in comparison with placebo.
Omarigliptin once-weekly monotherapy treatment has shown to be comparably effective to once-daily sitagliptin, and was generally well tolerated over 24 weeks in patients with type 2 diabetes.
A new DPP-4 inhibitor has been approved for the treatment of type 2 diabetes in Japan. By the end 2015, Merck plans on submitting omarigliptin for regulatory approval in the United Stated, followed by submission elsewhere. However, the trademark for omarigliptin in other countries has not yet been announced. Currently, worldwide, the clinical development program for omarigliptin includes 10 phase-3 clinical trials. These trials involve approximately 8,000 patients with type 2 diabetes.
- A new once-weekly DPP-4 inhibitor, Omarigliptin, has been approved in Japan
- Studies have shown that Omarigliptin significantly reduces HbA1c levels, along with reduced 2-hour postmeal glucose and fasting plasma glucose.
- By the end of this year, Merck plans to submit omarigliption for regulatory approval in the united states.
“Effect of Omarigliptin, a Novel Once weekly DPP-4 Inhibitor, in Japanese Patients with Type 2 Diabetes: A Placebo- and Sitagliptin-controlled Trial.” European Association for the Study of Diabetes. Japan. Web. 29 Sept.2015. <http://www.abstractsonline.com/Plan/ViewAbstract.asp>