Manufacturer: Novo Nordisk
FDA Approval Date: 12/22/2025
The two new indications for oral semaglutide are in combination with a reduced calorie diet and increased physical activity to reduce:
- Excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition
- The risk of major adverse cardiovascular (CV) events (MACE; CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with established CV disease and either obesity or overweight.
Clinical Profile
Semaglutide is a glucagon-like peptide-1 (GLP-1) initially approved to treat type 2 diabetes, and has added weight management indications under the brand name WEGOVY in 2021. Oral semaglutide has been available since 2019 under the brand name RYBELSUS for the treatment of type 2 diabetes. WEGOVY tablets are the first oral GLP-1 product approved by the FDA for weight-related indications.
Population
It is estimated that approximately 40% of the US adult population is obese
Pricing and Availability
WEGOVY tablets are priced slightly less than the injectable for the corresponding doses. It is worth noting the direct-to-consumer pricing for the tablets is $50 less per month than the injectable.
Management Strategy
Due to the small cost differential – expect similar management to injectable
References
IPD Analytics
Additional information: Press Release Prescribing Information
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