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 the drug. Novo Nordisk‘s blockbuster weight loss injection Wegovy as the company tries to regain market share from its chief rival Eli Lilly.

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

This high efficacy helped make Zepbound the obesity drug of choice among prescribers and patients, despite entering the U.S. market after Wegovy, and solidified Lilly’s position as the dominant player in the field.

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

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

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

In a separate phase three trial in patients with obesity and Type 2 diabetes, high doses of Wegovy showed an average weight loss of 14.1%. People with diabetes often have more difficulty losing weight than people without diabetes.

This marks the first approval of a GLP-1 therapy under the FDA’s new national priority voucher plan, which aims to reduce drug review times to one to two months for companies it says support U.S. national health priorities. The FDA launched the pilot plan in June.