Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes Gets Okay in Japan

Miriam E Tucker

Disclosures

September 29, 2015

The oral, once-weekly dipeptidyl peptidase-IV (DPP-4) inhibitor omarigliptin (Marizev, Merck/MSD) has been approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with type 2 diabetes.

The omarigliptin approval is the second approval of a once-weekly DPP-4 inhibitor in Japan; trelagliptin (Zafatek, Takeda) was approved there earlier this year, in March.

But neither of these once-weekly agents has yet been approved elsewhere in the world.

Omarigliptin will be available in 25-mg and 12.5-mg tablets. The approval is based on phase 3 trials, including one presented in September 2014 at the European Association for the Study of Diabetes meeting, in which 25 mg/week of omarigliptin was compared with the standard 50-mg/day sitagliptin (Januvia, Merck) starting dose in Japan.

In the 24-week trial, of a total 414 patients with type 2 diabetes who were inadequately controlled, those who received once-weekly omarigliptin had a significantly greater mean reduction in HbA1c from baseline compared with patients on placebo (0.66% vs 0.13%, P < .001) and had similar changes in HbA1c from baseline compared with patients who received daily sitagliptin (-0.66% vs -0.65%).

Omarigliptin also significantly reduced 2-hour postmeal glucose and fasting plasma glucose compared with placebo. The major treatment effect occurred by week 12.

Worldwide, the clinical development program for omarigliptin includes 10 phase 3 clinical trials involving approximately 8000 patients with type 2 diabetes.

Merck plans to submit omarigliptin for regulatory approval in the United States by the end of 2015, with submissions elsewhere to follow. The trademark for omarigliptin in other countries has not yet been announced.

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