Still basking in the afterglow of its Wegovy pill launch earlier this year, Novo has achieved another victory as it strives to make the most out of its blockbuster GLP-1 drug in an increasingly pressured obesity market.
On Thursday, the FDA approved Novo’s Wegovy HD—a higher, 7.2-mg dose of the injectable semaglutide drug—in adults with obesity. The nod came via the FDA’s new National Priority Voucher program and marks the fourth handed down so far under the regulatory framework, which seeks to dramatically speed up reviews for medical products judged to align with U.S. interests.
The strength of Novo’s new injection comes in well above the previous highest Wegovy pen maintenance dose of 2.4 mg. The new offering is cleared for use alongside increased physical activity and a reduced-calorie diet in people who have tolerated the 2.4-mg Wegovy dose for at least 4 weeks and still require additional weight reduction, according to a March 19 press release.
Novo plans to launch Wegovy HD in April, with the medication’s U.S. price to be revealed at that time, a Novo Nordisk spokesperson told Fierce. The higher dose will be available next month “through all channels where patients can access Wegovy,” Novo’s representative said, singling out brick-and-mortar pharmacies, certain telehealth providers like GoodRx, and the company’s own NovoCare Pharmacy.
Earlier in the year, Wegovy HD also won thumbs up from regulators in the United Kingdom and the European Union.
With the higher dose, Novo’s newly minted Wegovy formulation naturally comes with the appeal of greater weight-loss potential.
In the 72-week Step Up trial that helped win Wegovy HD its U.S. green light, patients on the 7.2-mg dose lost an average of 20.7% of their body weight if they adhered to treatment properly, compared to a 17.5% weight reduction for patients on the previous-highest 2.4 mg dose and a 2.4% reduction in the trial’s placebo cohort.
This presentation of the data is what’s known as an efficacy estimand, representing the treatment’s performance when assuming strict compliance to the dosing schedule. Novo also provided data on Wegovy HD’s performance using a treatment policy estimand, which includes patients who missed or discontinued doses or took other weight-loss medications.
When accounting for all patients in the Step Up trial, regardless of whether they stayed on treatment, patients on the highest dose lost an average of 18.8% of their body weight, versus 15.5% and 3.9% reductions for patients receiving Wegovy 2.4 mg and placebo, respectively.
Meanwhile, some 31% of patients on the 7.2-mg dose achieved 25% or more weight loss, nearly double the rate seen in the 2.4-mg cohort. No patients in the trial’s control arm shed that magnitude of weight, according to Novo’s release.
In its approval announcement, Novo noted that the high-dose green light holds the promise of the “highest weight loss to date” with injectable Wegovy.
The most common side effects reported with Wegovy HD included nausea, vomiting, dysesthesia (an unpleasant feeling on the skin), constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence—all of which have been recorded among the GLP-1 class.
Novo’s study assessed 1,407 adults with obesity who did not have diabetes.
Novo has been working to recoup its lead in the branded U.S. obesity market, which Wegovy ultimately ceded to rival Eli Lilly and its weight-loss counterpart Zepbound in the U.S. last year.
So far, the Danish drugmaker has racked up several wins to set the tone for 2026, beginning with the launch of its oral formulation of Wegovy on Jan. 5. Within the first two weeks of launch, the Wegovy pill had already logged numerically higher prescribing stats than either injectable Wegovy or Zepbound during the first two weeks of their respective launches, analysts at Jefferies wrote earlier this year.
Still, even as important catalysts like Wegovy HD and the Wegovy pill come into focus, Novo isn’t out of the woods yet. After releasing a sobering earnings forecast for 2026—which speculated that sales for the year will slide between 5% and 13%— the company’s share price plunged some 15% in early February, with trading briefly halted on the day due to volatility.
