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Novo Nordisk, a leading global healthcare company, announced that the US Food and Drug Administration (FDA) has approved Wegovy HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction long-term. The FDA awarded a Commissioner’s National Priority Voucher for Wegovy HD, accelerating its review and underscoring its potential to address critical patient needs and national health priorities in the US.
The accelerated approval is based on results from the STEP UP trial programme. In the STEP UP trial, semaglutide 7.2 mg injected once weekly demonstrated 20.7%1 mean weight loss in participants with obesity, and approximately one in three people experienced 25% or greater weight loss. In the STEP UP type 2 diabetes (T2D) trial, in participants with obesity and type 2 diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%1. In both trials, the well-known safety and tolerability profile of semaglutide was reaffirmed with semaglutide 7.2 mg, which was comparable to previous trials with semaglutide for weight management.
“Since its launch in 2021, Wegovy has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk,” said Mike Doustdar, president and CEO of Novo Nordisk. “Earlier this year, we launched the Wegovy pill, and 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%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy® HD to help even more people reach their weight and health goals.”
Novo Nordisk expects to launch Wegovy HD in a single-dose pen in the US in April 2026.
Wegovy 7.2 mg is already approved for adults with obesity in the EU and the UK. Novo Nordisk expects regulatory decisions in the EU and the UK on semaglutide 7.2 mg in a single-dose pen in the second half of 2026.
The STEP UP and STEP UP T2D phase 3 trials investigated the efficacy and safety of injectable semaglutide 7.2 mg in people with obesity with or without type 2 diabetes.
The 72-week STEP UP trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included approximately 1,400 adults with obesity. The 72-week STEP UP T2D trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to placebo in approximately 500 adults with obesity and type 2 diabetes.
Wegovy is approved as once-daily Wegovy pill (semaglutide tablet 25 mg) and once-weekly Wegovy injections (semaglutide 1.7 mg, 2.4 mg and 7.2 mg) by the FDA.
Wegovy is approved as a once-weekly injection by the EMA and by other regulatory authorities worldwide. The Wegovy pill is currently pending marketing approval from the EMA and other regulatory authorities.
Wegovy is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight. Furthermore, Wegovy injection is indicated to reduce excess body weight and maintain long-term weight reduction in paediatric patients aged 12 years and older. It is approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not in those with cirrhosis of the liver.
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Its purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. The company do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease.
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