Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes.

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults. Further, Ozempic is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease, states the company.

“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,” says Martin Lange, executive vice president, Development at Novo Nordisk. “The approval of the 2.0 mg dose allows more people with type 2 diabetes to achieve and maintain individualised glycaemic targets and remain on the same medication for longer as their needs evolve.”

The SUSTAIN FORTE trial

The FDA approval is based on the results from the SUSTAIN FORTE trial. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.

Expected launch second quarter of 2022

Novo Nordisk expects to launch Ozempic 2.0 mg in the United States in the second quarter of 2022. Ozempic 2.0 mg is now approved in the US, the EU, Canada and Switzerland.

Photo of Martin Lange: Novo Nordisk