FDA Approves 2.0 mg Dose of Semaglutide Injection for Type 2 Diabetes

The FDA has approved a 2.0 mg dose of semaglutide (Ozempic; Novo Nordisk) as a once-weekly subcutaneous injection for the treatment of adults with type 2 diabetes (T2D).

The action expands the indicated use of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), to include 0.5, 1.0, and 2.0 mg doses for the treatment of T2D, in addition to decreased risk of major adverse cardiovascular events in adults with both T2D and cardiovascular disease.In 2017, the FDA approved semaglutide at doses of up to 1 mg subcutaneously once weekly for the treatment of TD2 mellitus.

“We are pleased with the FDA approval for a higher 2.0 mg dose of Ozempic, which further supports our purpose of driving change in diabetes care,” Martin Lange, executive vice president of development at Novo Nordisk, said in a press release. “The approval of the 2.0 mg dose allows more people with type 2 diabetes to achieve and maintain individualized glycemic targets and remain on the same medication for longer as their needs evolve.”

The approval for T2D was based on results from the SUSTAIN FORTE trial of 2.0 mg semaglutide injection, which found that patients treated with a higher-dose of the GLP-1 RA experienced statistically significant and superior reductions in hemoglobin A1c (HbA1c) at week 40 compared with patients on 1.0 mg semaglutide.

The treatment was found to be as safe and well-tolerated among patients administered the higher dose of semaglutide as the 1.0 mg treatment cohort, with gastrointestinal events being the most common adverse effect reported.

The FDA previously granted approval to semaglutide as Wegovy in a 2.4 mg once-weekly injection dose for chronic weight management in adults with obesity or overweight status plus ≥1 weight-related condition.

The prior approval of Wegovy injection was based on the results of the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial program, which included 4 phase 3a clinical trials with approximately 4500 patients overall. These trials demonstrated that patients receiving semaglutide injection achieved a significant reduction in body weight compared with placebo. Both groups had used a reduced calorie meal plan and increased physical activity.

Semaglutide, available in 0.25, 0.5, 1.0, 1.7, and 2.4 mg strengths for titration purposes, is a once weekly subcutaneous injection authorized for use in adults with obesity or overweight with at least 1 other weight related-condition—such as T2D mellitus, hypertension, or dyslipidemia—alongside recommended lifestyle interventions. Such interventions include a reduced calorie diet, such as establishing a 500 kcal deficit per day, and average physical activity of 150 minutes per week.

In the STEP 1 trial, results showed that patients taking semaglutide injection achieved an average weight loss of 14.9% of body weight at 68 weeks compared with 2.4% body weight loss for placebo. In addition, 83.5% of patients achieved 5% or more body weight reduction in the semaglutide injection arm compared with 31.1% for placebo.

In a press release, Novo Nordisk said it intends to make the 2.0 mg semaglutide injection available in the second quarter of 2022.

Reference

Ozempic® 2.0 mg approved in the US for the treatment of type 2 diabetes. Novo Nordisk. [news release]. March 28, 2022. https://www.globenewswire.com/news-release/2022/03/28/2411445/0/en/Ozempic-2-0-mg-approved-in-the-US-for-the-treatment-of-type-2-diabetes.html