FDA approves high dose version of Novo Nordisk’s obesity drug Wegovy

The Food and Drug Administration on Thursday approved a higher-dose version of Novo Nordisk‘s blockbuster weight loss injection Wegovy, as the company pushes to win back market share from chief rival Eli Lilly.

Novo expects to launch the higher, 7.2-milligram dose of Wegovy in April. The Danish drugmaker is positioning that version to better compete with Lilly’s obesity drug Zepbound, which has proven to be more effective at promoting weight loss than the standard, 2.4-milligram dose of Wegovy.

That higher efficacy has helped Zepbound become the preferred obesity medication among prescribers and patients, even though it entered the U.S. market later than Wegovy, and has solidified Lilly’s position as the dominant player in the space.

The high-dose Wegovy helped patients with obesity lose an average 20.7% of their weight after 72 weeks in a phase three trial. The standard dose of Wegovy has shown around 15% weight loss on average in clinical trials.

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

“But even more importantly, I think it just gives patients another option if they’re not reaching their targets, and achieving some of these higher weight losses for certain patients,” he added.

In a separate phase three trial on patients with obesity and Type 2 diabetes, high-dose Wegovy demonstrated an average weight loss of 14.1%. People with diabetes typically have a harder time losing weight than people without the condition.

It marks the first approval of a GLP-1 treatment under the FDA’s new national priority voucher plan that aims to cut drug review times to one to two months for companies the agency says are supporting U.S. national health priorities. The FDA launched the pilot plan in June.