Novo Nordisk’s high-dose formulation of its blockbuster weight loss drug Wegovy has been approved by the FDA.
The agency approved Wegovy “HD,” a 7.2-mg injection of semaglutide, to reduce excess body weight and support long-term weight management, according to a March 19 news release from the drugmaker. The FDA had granted the therapy a Commissioner’s National Priority Voucher to accelerate review of the treatment, which Novo Nordisk said it expects to launch in the U.S. in April.
The approval was based on clinical trial program results. In a 72-week trial of about 1,400 adults with obesity, patients treated with the7.2-mg dose achieved “a 20.7% mean weight loss,” and approximately one-third “experienced 25% or greater weight loss,” the release said.
In a separate 72-week trial of approximately 500 adults with obesity and Type 2 diabetes, the dose was linked to a mean weight loss of 14.1%. The safety and tolerability profile was consistent with earlier trials of semaglutide for weight management, Novo Nordisk said.
The approval is the latest development in Novo Nordisk’s ongoing expansion of its GLP-1 portfolio. In January, the company launched an oral version of Wegovy priced at $299 per month for higher doses through a self-pay platform. It has also said it will lower U.S. list prices for Wegovy, Ozempic and Rybelsus to $675 per month starting Jan. 1, 2027 — a reduction of approximately 50% for Wegovy and 35% for Ozempic.
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