FDA Approves 2.0 mg Dose of Semaglutide

On March 28, Novo Nordisk announced the US FDA had granted approval to their 2.0 mg dose of semaglutide (Ozempic) as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes and to reduce the risk of major cardiovascular events in adults with type 2 diabetes and history of CVD.

The US Food and Drug Administration has approved a 2 mg dose of semaglutide (Ozempic) for use in patients with type 2 diabetes, according to a statement from Novo Nordisk.

Announced on March 29, the approval for the 2 mg dose of Novo Nordisk’s once-weekly GLP-1 RA is approved as an adjunct therapy to accompany diet and exercise for improving blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and a history of cardiovascular disease.

“Type 2 diabetes is a complex disease that can progress over time even if a person is managing it with medication, diet and exercise,” said Juan Pablo Frias, MD, PhD, medical director of Velocity Clinical Research, Los Angeles and principal investigator of SUSTAIN FORTE. “With its proven safety and efficacy, Ozempichelps deliver on blood glucose control and offers major cardiovascular event risk reduction in adults with type 2 diabetes and known heart disease, plus it can help many patients lose some weight. With a 2 mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift.”

With approval based on the results of the SUSTAIN FORTE trial, Novo Nordisk expects semaglutide to be available in doses of 0.5 mg, 1 mg, and 2 mg in the US shortly, according to the aforementioned statement. Originally presented at ADA 2021, the 40-week phase 3b trial compared once-weekly semaglutide 2.0 mg vs the 1.0 mg formulation as an add-on to metformin with or without sulfonylureas in 961 patients with type 2 diabetes and an HbA1c of 8.0-10.0%.

Results of the trial indicated semaglutide 2.0 mg was associated with statistically significant and superior reductions in HbA1c (2.2% vs 1.9% [ETD, -0.23 [95% CI, -0.36 to -0.11]; P <.001]) and body weight (-14.1 lb vs -12.5 lb; ETD, -0.93 [95% CI, -1.68 to -0.18]; P=.016) than the 1.0 mg dose. Further analysis indicated those receiving in the semaglutide 2.0 arm experienced a greater proportion of patients achieving an HbA1c less than 7% (67.6% vs 57.5%; OR, 1.60 [95% CI, 1.21-2.13]; P=.001) and achieving a body weight reduction greater than 5% (59.2% vs 51.3%; OR, 1.41 [95% CI, 1.08-1.84]).

In subgroup analyses, which were also presented at ADA 2021, results suggested semaglutide 2.0 mg was associated with greater reductions in HbA1c and body weight compared to semaglutide 1.0 mg, irrespective of baseline HbA1c or BMI.

“Ozempic is at the helm of helping Novo Nordisk drive change in diabetes care, with more than one million people with type 2 diabetes in the United States treated with Ozempic,” said Doug Langa, executive vice president, North America operations and president of Novo Nordisk Inc. “With Ozempic now available in a variety of dosing strengths, we are optimistic we can help even more people living with type 2 diabetes who require more blood sugar control experience the benefits of Ozempic.”