Health
Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg
Today, Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity.1 Under the CNPV expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing.
About this update from Novo Nordisk A/s Class B
[{"type":"list","items":[{"val":[{"type":"text","content":"If approved, investigational semaglutide 7.2 mg injection would offer the optionality of a higher dose for greater weight loss potential in adults with obesity1,2","length":162,"tagName":"p"}]},{"val":[{"type":"text","content":"In the STEP UP phase 3 trial, adults with obesity taking semaglutide 7.2 mg as directed lost an average of 20.7% body weight2,3* ","length":128,"tagName":"p"}]},{"val":[{"type":"text","content":"The supplemental New Drug Application (sNDA) will be reviewed under the FDA's Commissioner's National Priority voucher (CNPV) pilot, which accelerates review for products addressing major national health priorities1","length":223,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":513,"olType":false},{"type":"text","content":"PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Nov. 26, 2025 /PRNewswire/ -- Today, Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity.1 Under the CNPV expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing.","length":480,"tagName":"p"},{"type":"text","content":""Our pipeline is rapidly expanding to meet the needs of people living with obesity, and this submission—under the FDA's new expedited review program—marks an exciting step forward," said Anna Windle, PhD, senior vice president, Clinical Development, Medical and Regulatory Affairs, Novo Nordisk. "If approved, semaglutide 7.2 mg would bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring. We look forward to working with the FDA to bring this fast-tracked option to the obesity community."","length":625,"tagName":"p"},{"type":"text","content":"The sNDA includes results from STEP UP, a 72-week phase 3, randomized, double-blind, placebo-controlled and active-controlled superiority trial that evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg compared to placebo and semaglutide 2.4 mg, as an adjunct to lifestyle intervention, in 1,407 adults with obesity (BMI ≥30 kg/m2).2 Pat...