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FDA approves high-dose model of Novo Nordisk’s weight problems drug Wegovy

The logo of pharmaceutical company Novo Nordisk is seen outside its offices in Bagsvaerd, Copenhagen, Denmark, on February 4, 2026.

Tom Little | Reuters

The Food and Drug Administration approved a higher-dose version on Thursday Novo NordiskWegovy, the blockbuster weight loss injection, as the company pushes to regain market share from its main rival Eli Lilly.

Novo expects to bring the higher Wegovy dose of 7.2 milligrams to market in April. The Danish drugmaker is positioning this version to better compete with Lilly’s obesity drug Zepbound, which has been shown to be more effective in weight loss than the standard 2.4-milligram dose of Wegovy.

This higher potency has helped make Zepbound the obesity drug of choice among prescribers and patients, even though it entered the U.S. market later than Wegovy, and has solidified Lilly’s position as a dominant player in the space.

In a Phase III study, high-dose Wegovy helped patients with obesity lose an average of 20.7% of their weight after 72 weeks. The standard dose of Wegovy has shown an average weight loss of about 15% in clinical trials.

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“I think it really makes it more competitive and really reduces the delta there,” Dr. Jason Brett, chief medical officer for the U.S. at Novo Nordisk, said in an interview Thursday ahead of the approval.

“But more importantly, I think, it just gives patients another option if they’re not meeting their goals, and in certain patients, some of those higher weight losses are achieved,” he added.

In a separate Phase III study in patients with obesity and type 2 diabetes, high-dose Wegovy showed an average weight loss of 14.1%. People with diabetes typically find it more difficult to lose weight than people without the condition.

It is the first approval of a GLP-1 treatment under FDA’s new National Priority Voucher plan, which aims to shorten drug review times to one to two months for companies that the agency says support U.S. national health priorities. The FDA launched the pilot plan in June.

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