-+ 0.00%
-+ 0.00%
-+ 0.00%

The FDA Action Date To Decide On The Wegovy Oral Formulation NDA Will Be In Q4 2025

Benzinga·05/02/2025 18:30:37
Listen to the news

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.1,3 Patients with diabetes were excluded.1,3

OASIS 4 included a 64-week treatment period including a 12-week dose escalation, and a 7-week off-treatment follow-up period.1,3 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.1,3

The FDA action date to decide on the Wegovy® oral formulation NDA will be in Q4 2025.2