Novo Nordisk application for oral Wegovy accepted by USFDA for weight loss

The FDA application is based on results from OASIS 4, a 64-week phase 3 randomized, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI >/= 30 kg/m2) or overweight (BMI >/= 27 kg/m2) with one or more comorbidities. Patients with diabetes were excluded.

OASIS 4 included a 64-week treatment period including a 12-week dose escalation, and a 7-week off-treatment follow-up period. In total, 307 participants were randomized 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, as an adjunct to lifestyle intervention for 64 weeks.

The FDA action date to decide on the Wegovy oral formulation NDA will be in Q4 2025.

Wegovy (semaglutide) injection 2.4 mg is currently approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.