Novo Nordisk Receives FDA Approval for 2mg Dose of GLP-1 Agonist Ozempic (Semaglutide)

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Recently, Novo Nordisk announced that the US FDA has approved Ozempic (semaglutide) 2mg injection.

This drug is a glucagon-like peptide-1 (GLP-1) analog administered once weekly via subcutaneous injection as an adjunct to diet and exercise: (1) to improve glycemic control in adults with type 2 diabetes; (2) to reduce the risk of major cardiovascular events (heart attack, stroke, death) in adults with type 2 diabetes and established cardiovascular disease.

Ozempic is not a weight-loss drug, but it can help patients lose weight. Ozempic will now be available in three therapeutic doses (0.5mg, 1mg, 2mg) to help people with type 2 diabetes reach their blood sugar (A1C) goals, including those with higher A1C levels who have not been able to achieve their A1C targets.

In the SUSTAIN Phase 3 clinical trial program, up to 73% of patients with type 2 diabetes achieved the American Diabetes Association (ADA) blood glucose treatment target (A1C <7%) after receiving Ozempic 1mg. Nevertheless, some patients still did not reach this blood glucose goal.

Ozempic is a human GLP-1 analog that promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner. It can effectively lower blood glucose levels in patients with type 2 diabetes, with a low risk of hypoglycemia. Additionally, semaglutide can induce weight loss by reducing appetite and food intake. Moreover, in type 2 diabetes patients with cardiovascular disease, Ozempic can also effectively reduce the risk of major adverse cardiovascular events (MACE).

Previously, the approved treatment doses for Ozempic were 0.5mg and 1mg. In China, the 0.5mg and 1mg injectable forms of Ozempic (Novo Nordisk's Rybelsus) were approved in April 2021 to improve blood glucose levels in patients with type 2 diabetes.

FDA Approves Ozempic 2mg Injection Based on SUSTAIN FORTE Trial ResultsThe FDA approval of Ozempic 2mg injection was based on the results of the SUSTAIN FORTE trial, in which the enrolled patients had an average baseline A1C of 8.9%, comparing Ozempic 2mg with Ozempic 1mg. Data showed that by week 40 of treatment, the A1C reduction was 2.1% in the Ozempic 2mg group, compared to 1.9% in the Ozempic 1mg group, with a statistically significant treatment difference (p<0.01).

Moreover, the average baseline weight of patients in the trial was 219 pounds. At week 40 of treatment, the Ozempic 2mg group lost 14.1 pounds, and the Ozempic 1mg group lost 12.5 pounds, with no statistically significant difference.

During the trial, no new safety signals were found for the two doses of Ozempic. The most common adverse events were gastrointestinal events. The frequency of gastrointestinal adverse events was higher in the Ozempic 2mg group (34.0%) compared to the Ozempic 1mg group (30.8%).

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