FDA Approves Greater Semaglutide Injection Dose for Type 2 Diabetes

The US Food and Drug Administration (FDA) has approved 2.0 mg once-weekly subcutaneous injection semaglutide (Ozempic) for the treatment of adults with type 2 diabetes (T2D).

The approval granted to Novo Nordisk expands the indicated use of the GLP-1 agonist to include 0.5, 1.0 and 2.0 mg doses for the treatment of T2D, as well as indications for reduced major adverse cardiovascular event risk in adults with both T2D and cardiovascular disease.

Semaglutide was also previously approved by the FDA as Wegovy, a 2.4 mg once-weekly injection therapy for chronic weight management in adults with obesity or overweight status plus ≥1 weight-related condition.

Data supporting 2.0 mg semaglutide injection for T2D was derived from the SUSTAIN FORTE trial, in which patients treated with the higher-dose GLP-1 agonist achieved statistically significant and superior reductions in hemoglobin A1c (HbA1c) at week 40 versus patients on 1.0 mg semaglutide.

The greater-dose semaglutide treatment arm reported similarly safe and well-tolerated outcomes as the 1.0 mg treatment arm, with gastrointestinal events being the most commonly reported adverse effect.

In a statement accompanying the FDA ruling, Novo Nordisk leadership shared intent to make 2.0 mg semaglutide injection available in the second quarter of 2022, and their anticipation of its value in glycemic and cardiovascular management.

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