FDA approves higher dose of Wegovy as Novo Nordisk seeks to reclaim market share

The U.S. Food and Drug Administration (FDA) has approved a higher dosage of the weight-loss injection Wegovy from the Danish pharmaceutical company Novo Nordisk, CNBC reports. The decision comes amid intensifying competition with its main rival, Eli Lilly, and an effort to reclaim market positions in the rapidly growing obesity therapy segment.

The new 7.2 mg dose of Wegovy is expected to be launched on the market in April. The company is positioning it as a more competitive alternative to Eli Lilly’s Zepbound—a product that has so far demonstrated higher weight-loss efficacy compared to the standard 2.4 mg dose of Wegovy.

Clinical data shows that in a Phase III study, patients with obesity treated with the higher dose of Wegovy achieved an average weight reduction of 20.7% over a 72-week period. In comparison, the standard dose leads to an average weight loss of approximately 15%. In a separate study involving patients with obesity and type 2 diabetes, an average reduction of 14.1% was reported, a group that traditionally faces greater challenges with weight loss.

According to Dr. Jason Brett, Executive Director of Medical Affairs for Novo Nordisk in the U.S., the new dosage significantly improves the product’s competitiveness: “This effectively closes the gap and makes the therapy more competitive. More importantly, it provides an additional option for patients who do not achieve target results with existing therapies.”

The higher efficacy of Zepbound has contributed to its rapid establishment as a preferred choice among doctors and patients, despite its later entry into the U.S. market, and has solidified Eli Lilly’s leadership position in the segment.

The approval of the new Wegovy dose is also the first under the FDA’s new priority voucher program, aimed at accelerating drug evaluations—to within one to two months—for companies contributing to U.S. national health priorities. The program was launched in June and serves as a strategic tool to expedite access to innovative therapies.