FDA Approves Novo Nordisk's Ozempic 2.0 Mg To Treat Type 2 Diabetes

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

The approval was 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.

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.

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.