Still basking in the afterglow of launching Wegovy tablets earlier this year, Novo has scored another victory as it strives to make the most of its blockbuster GLP-1 drug in an increasingly pressured obesity market.
On Thursday, the FDA approved Novo’s Wegovy HD, a higher-dose 7.2 mg semaglutide injection, for obese adults. The agreement, made through the FDA’s new National Priority Voucher Program, is the fourth approved to date under a regulatory framework designed to dramatically speed up the review of medical products determined to be in U.S. interest.
The strength of Novo’s new injectable formulation far exceeds the previous highest Wegovy pen maintenance dose of 2.4 mg. According to a March 19 press release, the new product is approved for use in conjunction with increased physical activity and a calorie-restricted diet for people who can tolerate the 2.4 mg Wegovy dose for at least four weeks and still need additional weight loss.
A Novo Nordisk spokesperson told Fierce that Novo plans to launch Wigoby HD in April and that the drug’s U.S. price will be disclosed at that time. A Novo representative said the higher doses will be available next month “through all channels where patients can access Wegovy,” citing brick-and-mortar pharmacies, certain telemedicine providers such as GoodRx, and the company’s NovoCare Pharmacy.
Earlier this year, Wegovy HD also received positive reviews from regulators in the UK and European Union.
Novo’s newly developed Wegovy formulation naturally has greater weight loss potential as the dose increases.
In the 72-week step-up study that helped get Wegovy HD the green light in the U.S., patients who received the 7.2 mg dose lost an average of 20.7 percent in weight when properly adhered to treatment, compared to a 17.5 percent weight loss in patients who received the highest-ever 2.4 mg dose and a 2.4 percent decrease in the study’s placebo cohort.
This presentation of data is known as the efficacy estimate and represents the performance of the treatment assuming that the dosing schedule is strictly followed. Novo also provided data on Wegoby HD’s performance using treatment policy estimates. This also includes patients who have missed or discontinued doses or have taken other weight loss medications.
Across all patients in the Step-Up study, regardless of whether they continued treatment, those on the highest dose experienced an average weight loss of 18.8%, compared with 15.5% and 3.9% for those receiving Wegovy 2.4 mg and placebo, respectively.
Meanwhile, approximately 31% of patients receiving the 7.2 mg dose achieved weight loss of 25% or more, nearly double the rate seen in the 2.4 mg cohort. No patient in the control group of the trial lost this much weight, according to a release from Novo.
In its approval announcement, Novo said the green light for the higher dose promises the Wegovy injection’s “highest weight loss to date.”
The most common side effects reported with Wegovy HD include nausea, vomiting, paresthesia (unpleasant sensations on the skin), constipation, abdominal pain, fatigue, headache, dizziness, hair loss, and bloating, all of which were recorded in the GLP-1 class.
Novo’s study evaluated 1,407 obese adults without diabetes.
Novo has been working to regain leadership in the branded U.S. obesity market, which Wegoby ultimately ceded last year to rival Eli Lilly and U.S. weight-loss provider Zepbound.
The Danish drugmaker has scored several wins so far to set the tone for 2026, starting with the launch of oral formulation Wegoby on January 5th. Within the first two weeks of its launch, WeGovy tablets were already posting higher prescription statistics than the injectables WeGoby and Zepbound in the first two weeks of their respective launches, Jefferies analysts wrote earlier this year.
Still, despite significant catalysts like Wegovy HD and Wegovy pills gaining traction, Novo is not out of the woods yet. The company’s stock price plummeted about 15% in early February after it issued a grim earnings forecast that estimated sales would decline between 5% and 13% in 2026, and trading was suspended that day due to volatility.
