PLAINSBORO, N.J.– Novo Nordisk announced U.S. Food and Drug Administration (FDA) approval of a new higher dose of Wegovy, Wegovy HD (semaglutide) injection 7.2 mg, which demonstrated substantial weight loss in adults with obesity in the STEP UP trial.
Wegovy HD can be used along with a reduced calorie diet and increased physical activity to help adults with obesity lose weight and keep it off, provided they have tolerated the 2.4 mg dosage for at least 4 weeks and additional weight reduction is clinically indicated. This new update supplements the existing Wegovy label, which also has distinct indications for Wegovy not offered by any other GLP-1 medication for weight loss.
"We are excited to bring Wegovy HD injection to adults with obesity who are looking for powerful weight loss, as no other weight loss medicine has been studied to show superiority to Wegovy HD," said Jamey Millar, executive vice president, US Operations of Novo Nordisk. "In addition to significant weight loss, Wegovy is the only GLP-1 for adults with obesity that is proven to reduce the risk of events such as stroke, heart attack, or cardiovascular death in those who also have known heart disease. Today's milestone expands the strong clinical profile of Wegovy that includes multiple indications that no other GLP-1 for weight loss can claim."
Prior to this approval, the highest approved dose of Wegovy injectable for weight loss was 2.4 mg, which is also indicated, along with a reduced calorie diet and increased physical activity, to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
The FDA approval of Wegovy HD is based on the results of the STEP UP trial program, which included STEP UP, a 72-week study which evaluated the efficacy and safety of once-weekly Wegovy 7.2 mg compared to placebo and Wegovy 2.4 mg, as an adjunct to lifestyle intervention in 1,407 adults with obesity (BMI 30 kg/m2 or greater), without diabetes.
The most common adverse reactions reported with Wegovy HD were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence. In clinical trials, dysesthesia was reported at a higher rate with Wegovy HD compared to Wegovy 2.4 mg and placebo. Events related to a clinical picture of altered skin sensation such as sensitive skin, hyperesthesia, dysesthesia and paresthesia were reported by a higher proportion of participants, and at a higher rate, in the Wegovy HD arm (22%), compared to treatment with Wegovy 2.4 mg (6%) and placebo (0.3%).
"Wegovy HD represents an important new tool in obesity management, allowing clinicians to better tailor treatment strategies and help improve outcomes," said W. Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. "The weight loss demonstrated with Wegovy HD could reshape healthcare professionals' expectations about what outcomes are possible for their patients with Wegovy."
Wegovy HD will be available in April through all channels where patients can access Wegovy including 70,000 plus pharmacies in the US like CVS and Costco, select telehealth providers, NovoCare Pharmacy, GoodRx, and others. Additional information on coverage and savings options for eligible patients, including other programs designed to help reduce out-of-pocket costs, will also be available at that time.
