FDA OKs Once-Weekly Ozempic for T2D

— Approval based on results of SUSTAIN trial program

by Kristen Monaco, Staff Writer, 番茄社区 December 5, 2017

This article is a collaboration between 番茄社区 and:

The FDA approved semaglutide (Ozempic), a once-a-week injectable drug for patients with type 2 diabetes, .

The once-weekly GLP-1 receptor agonist is indicated for use in adults with type 2 diabetes, in conjunction with diet and exercise in order to improve glycemic control.

The approval was based upon findings of a phase IIIa SUSTAIN clinical trial program, which reported a significant improvement in HbA1c, with an added benefit of weight loss. The program also included the SUSTAIN-6 cardiovascular (CV) outcome trial, which showed a 26% risk reduction for major adverse CV events. It also follows the recommendation of an FDA advisory panel, who voted 16-0 in favor of approval in October.

Two doses of semaglutide -- 0.5 mg or 1 mg -- will be available in pre-filled pens in the U.S. by early 2018, according to Novo Nordisk. The treatment is currently under review for approval in Japan and Europe.

Novo is currently assessing an oral form of the GLP-1 treatment, with promising findings from a phase II study recently released.

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she鈥檚 worked at the company since 2015.