Novo Nordisk A/S (NASDAQ:NVO) received U.S. Food and Drug Administration approval on Monday for the first oral version of its blockbuster weight-loss medication Wegovy, setting the stage for a January launch that will bypass traditional insurance hurdles.
The approval of the 25 mg daily pill marks a watershed moment in the obesity market, transitioning the high-demand GLP-1 therapy from a weekly injection to a more convenient oral tablet.
The Danish drugmaker is moving aggressively to reclaim market share from U.S. rival Eli Lilly & Co., which is awaiting a regulatory decision on its own weight-loss pill, orforglipron, expected by March 2026.
To turbocharge adoption, Novo is debuting a "self-pay" strategy that targets the growing segment of consumers willing to pay out-of-pocket for effective treatments.
Under a landmark agreement reached with the Trump administration in November, Novo will offer starter doses of the Wegovy pill for $149 per month to Medicare, Medicaid, and cash-paying patients.
The medication will be distributed through a sprawling network of retail pharmacies—including CVS and Walmart—and digital health platforms such as Ro, GoodRx, and WeightWatchers.
The pivot to cash-pay channels comes as the share of Wegovy prescriptions paid for without insurance has already doubled into the double digits this year.
Novo executives believe the pill format will break the "needle barrier" for millions of patients who have resisted injectable therapies.
Clinical data from the OASIS 4 trial supported the approval, showing that the 25 mg pill delivered a 16.6% average weight reduction over 64 weeks—performance nearly identical to the 2.4 mg injectable version.
The stakes are high for Novo, which has seen its market capitalization fluctuate amid supply constraints and the rise of cheaper, unapproved compounded versions of semaglutide.
By pricing the pill at $149 through the administration's "TrumpRx" initiative, Novo aims to undercut the compounding market and establish an early lead in the oral obesity segment.