FDA approves Wegovy HD, a 7.2 mg semaglutide shot, under priority voucher pilot

The FDA approved Wegovy HD, a 7.2 mg once-weekly semaglutide injection, on March 19, 2026, for long-term weight loss and weight maintenance in adults who have obesity, or who are overweight with at least one weight-related condition ^[1]. The agency cleared the higher dose 54 days after the application was filed and counted it as the fourth product approved under the Commissioner's National Priority Voucher pilot ^[1][3].

Novo Nordisk, which markets Wegovy, said it expects to sell the dose in a single-dose pen in the US beginning in April 2026 ^[3]. The 7.2 mg dose is already approved in the European Union and the United Kingdom ^[3].

The FDA said the higher dose produced additional average weight loss compared with doses already on the market, with side effects consistent with what is known about semaglutide ^[1]. In the phase 3 STEP UP trial, which enrolled 1,407 adults with obesity, participants on 7.2 mg lost 18.7% of body weight on average after 72 weeks, against 3.9% for those on placebo. Just over 31% of people on the higher dose lost at least a quarter of their weight ^[3]. Novo Nordisk's announcement described the program as showing 20.7% mean weight loss ^[3]. The reason the two figures differ has not been explained.

A second trial, STEP UP T2D, enrolled about 512 adults who had both obesity and type 2 diabetes. Average weight loss there was 13.2% on 7.2 mg compared with placebo, and 21.3% of participants lost 20% or more ^[3]. The FDA said the higher dose lowered blood sugar, measured as hemoglobin A1C, about as much as the lower dose in this group ^[1].

Gastrointestinal problems were the most frequently reported side effects: nausea, vomiting, diarrhea, constipation and abdominal pain ^[1]. The agency also flagged a reaction that stood out. Altered skin sensation, described as sensitivity, pain or burning, was common, appeared more often at 7.2 mg than at lower doses, and usually went away on its own or after a dose reduction. The FDA said it is conducting further investigations into it ^[1]. In the diabetes trial, that reaction was recorded in 18.9% of people on 7.2 mg, 4.9% on 2.4 mg and none on placebo ^[3].

Wegovy's boxed warning about a potential risk of thyroid C-cell tumors, based on rodent studies, still applies. The drug is not for people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. The approval was granted to Novo Nordisk ^[1].

Why it matters for patients

Before this approval, the highest Wegovy injection dose sold in the US was 2.4 mg, alongside a 25 mg once-daily pill ^[3]. People who have not reached their weight goals on 2.4 mg now have a higher step available within the same drug rather than switching medications. In the trial, the higher dose group lost more weight on average than the placebo group ^[3]. How many people who stall on 2.4 mg would lose additional weight on 7.2 mg has not been reported.

The extra weight loss came with more reports of altered skin sensation: about one in five people in the diabetes trial on 7.2 mg, compared with about one in twenty on 2.4 mg ^[3]. The FDA's investigation into that reaction is open ^[1]. The boxed warning and the conditions that rule out use are unchanged ^[1].

Novo Nordisk has not disclosed a list price for Wegovy HD or how insurers will treat it, and whether it will be covered on the same terms as the 1.7 mg and 2.4 mg pens has not been reported.

What happens next

Novo Nordisk expects the US launch in a single-dose pen in April 2026 ^[3]. The FDA plans a public hearing in June on the voucher program, with a Federal Register notice to come first ^[1]. Under the same program, the FDA approved Eli Lilly's obesity pill Foundayo (orforglipron) on April 1, 2026, two weeks after Wegovy HD ^[2]. Lilly said it would sell the pill for up to $299 a month for patients who keep renewing their prescriptions ^[2].

The voucher program has drawn criticism. STAT reported that agency insiders described it as a vehicle for political interference, and that Lilly received its voucher through a White House deal to lower prices on its obesity drugs ^[2]. Reuters reported that Lilly pressed the agency for a faster answer on whether its application was complete; a Lilly spokesperson told Reuters the company expected a thorough review and a science-based decision ^[2].