- The FDA has approved Novo Nordisk A/S's (NYSE:NVO) 2.0 mg dose of Ozempic (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analog for type 2 diabetes.
- Ozempic is now approved in the US at 0.5 mg,1.0 mg, and 2.0 mg doses to treat type 2 diabetes in adults. Further, Ozempic is indicated to reduce the risk of major cardiovascular events.
- The FDA approval is based on the results from the SUSTAIN FORTE trial.
- Related: Novo Nordisk Doubles 2025 Sales Target On Strong Wegovy Demand.
- 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. Both doses of semaglutide appeared to have a safe and well-tolerated profile in the trial.
- The most common adverse events were gastrointestinal. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.
- Novo Nordisk expects to launch Ozempic 2.0 mg in the United States in Q2 of 2022.
- Price Action: NVO shares are up 3.20% at $111.36 during the market session on the last check Tuesday.
