Japan approves Novo Nordisk’s once-weekly Type II diabetes drug

The Japanese Ministry of Health, Labor and Welfare gave Novo Nordisk (NYSE:NVO) the green light to market its once-weekly type II diabetes drug, Ozempic, Reuters reported today.

The pharma company’s drug, semaglutide, is a glucagon-like peptide-1 analog that mimics an intestinal hormone to trigger insulin production in people with diabetes.

Novo Nordisk expects to launch Ozempic in Japan in the next few months, after it has landed reimbursement.

In the U.S., one of the nation’s largest pharmacy benefit managers, Express Scripts, announced last month that it plans to include Ozempic in its 2018 formulary. The move puts Ozempic directly in competition with Eli Lilly‘s (NYSE:LLY) once-weekly Trulicity drug. Both products will also go up against AstraZeneca‘s (NYSE:AZN) once-weekly Bydureon medication.

A spokesperson for Novo Nordisk told Reuters that being a part of Express Script’s formulary grants the company access to a “single-digit share” of the overall GLP-1 market in the U.S.

In one 40-week trial involving 1,200 patients, Ozempic succeeded in lowering glucose levels in patients with Type II diabetes and demonstrated statistically significant results compared to Lilly’s compound.

Ozempic and other once-weekly GLP-1 compounds are traditionally administered via injection. But last month, Novo Nordisk reported data from a late-stage trial of its oral formulation of semaglutide. Novo Nordisk is the first to take its oral formulation into large clinical studies.

The 26-week Pioneer I trial evaluated the efficacy and safety of a 3-, 7- and 14-mg dose of oral semaglutide compared to a placebo in 703 people with Type II diabetes.

The Phase III study met its primary endpoint, showing significant improvements in long-term blood sugar for patients taking any of the three doses of oral semaglutide. Novo Nordisk also noted that participants taking the 14-mg dose of semaglutide showed significant weight loss compared to people taking the placebo.

Importantly, the drug was well-tolerated, with 5-16% of people given semaglutide reporting nausea versus 6% of the group treated with a placebo.

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