Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration approved Wegovy HD, a higher-dose version of its weight-loss medication containing 7.2 mg of semaglutide administered once weekly by injection.

The FDA granted the approval under its Commissioner's National Priority Voucher pilot program, which accelerates review for products addressing critical national health priorities. The company expects to launch Wegovy HD in the U.S. in April 2026.

In the STEP UP clinical trial, participants with obesity who received semaglutide 7.2 mg achieved a mean weight loss of 20.7%. Approximately one-third of patients achieved weight loss of 25% or greater. A separate trial in participants with both obesity and type 2 diabetes showed a mean weight loss of 14.1%.

The 72-week STEP UP trial included approximately 1,400 adults with obesity and compared the 7.2 mg dose to the currently approved 2.4 mg dose and placebo, alongside lifestyle interventions. The STEP UP T2D trial involved approximately 500 adults with obesity and type 2 diabetes.

"With the accelerated approval of Wegovy HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%," said Mike Doustdar, president and CEO of Novo Nordisk.

Wegovy HD complements the existing Wegovy 2.4 mg injection, which is already approved in the U.S. for weight management and cardiovascular risk reduction. The company also offers a daily Wegovy pill containing 25 mg of semaglutide.

Semaglutide 7.2 mg is already approved for adults with obesity in the European Union and the United Kingdom. Novo Nordisk expects regulatory decisions in these regions for the single-dose pen formulation in the second half of 2026.