The FDA has approved Novo Nordisk’s oral Wegovy, marking the first pill-form GLP-1 drug for chronic weight management in the U.S. Novo Nordisk secures a first-mover advantage by beating competitor Eli Lilly to market with an oral version.
This approval could potentially broaden patient access and reshape the obesity treatment landscape amid ongoing insurance coverage challenges.
The U.S. Food and Drug Administration has granted approval for Novo Nordisk’s once-daily oral Wegovy (semaglutide) pill, authorizing its use for chronic weight management in adults with obesity or who are overweight with at least one weight-related condition.
This landmark decision introduces the first oral GLP-1 receptor agonist medication for weight loss in the United States, providing a new alternative to existing injectable therapies like Wegovy injections and Eli Lilly’s Zepbound (tirzepatide).
According to clinical trial data cited by the company, participants with obesity who took the oral semaglutide pill over 64 weeks achieved an average weight reduction of 16.6%, demonstrating efficacy comparable to the injectable form of Wegovy.
Novo Nordisk anticipates a full commercial launch in January, with the pill produced in the U.S. to ensure a robust supply chain. The announced price for a 1.5-mg starter dose is set at $149 per month with available savings programs, and the medication will be distributed through pharmacies and select telehealth providers.
This approval arrives amidst soaring demand for GLP-1 drugs and complex insurance landscapes. While coverage for these medications is evolving, significant barriers remain.
A recent GoodRx report indicates that even with increased coverage in 2025, nearly 90% of insured patients still face restrictions like prior authorization or step therapy for Wegovy. In a significant policy shift, the Centers for Medicare & Medicaid Services recently unveiled a voluntary program to cover GLP-1 drugs for weight loss under Medicaid and Medicare Part D, following earlier actions to negotiate lower drug prices for federal programs.
For patients without coverage or facing high out-of-pocket costs, prescription savings platforms offer a critical pathway. Services like GoodRx report average monthly savings of approximately $281 on medications like semaglutide and tirzepatide, which can translate to annual savings of around $3,000.
These platforms also provide dedicated programs to help patients navigate access to FDA-approved brand-name GLP-1 medications, potentially easing the financial burden for those seeking treatment.
