FDA Clears 7.2 Milligram Dose of Wegovy Weight Loss Drug
The FDA approved a 7.2-milligram dose of Wegovy under a fast-track program. Novo Nordisk expects to launch the higher dose in a single-dose pen this April.
Novo Nordisk A/S, headquartered in Denmark, has announced that the Food and Drug Administration has approved a higher 7.2-milligram dose of its weight-loss drug, Wegovy. This regulatory milestone was achieved through the National Priority Voucher program in the United States, which allows for expedited reviews of one to two months compared to the standard ten-to-twelve-month window. The approval arrives as the Danish drugmaker contends with significant competition from Eli Lilly and Company and broader efforts to reduce pharmaceutical costs. To maintain its market position, the company previously launched an oral version of the treatment to appeal to patients seeking needle-free options. Results from a 72-week late-stage clinical trial involving 1,407 participants showed that those on the 7.2-mg dose achieved an average weight loss of 20.7%. In comparison, patients on the 2.4-mg dose saw an average reduction of 17.5%. > The approval reflects a step in the right direction for Novo, though the company still faces an uphill battle as it fights to regain share from Lilly. According to BMO Capital Markets analyst Evan Seigerman, the company remains in a challenging position despite the new approval. The 7.2-mg dose is scheduled for a U.S. launch in April via a single-dose pen, with pricing to be disclosed at launch. While the dose is already available in the United Kingdom and the European Union as a three-injection regimen, the single-dose pen version is awaiting regulatory decisions in those markets, expected in late 2026.
