Novo Nordisk Soars on FDA Approval of Oral Wegovy Pill
The decision clears the path for the first pill-based GLP-1 treatment for weight management, intensifying the rivalry with Eli Lilly in the lucrative obesity market.
Novo Nordisk (NVO) shares surged nearly 8% in after-hours trading after the U.S. Food and Drug Administration (FDA) approved a pill version of its blockbuster weight-loss drug, Wegovy. The landmark decision, announced late Monday, makes oral semaglutide the first-ever pill-based GLP-1 receptor agonist approved for chronic weight management in the United States, a significant milestone for the Danish pharmaceutical giant.
The approval represents a pivotal strategic victory for Novo Nordisk, offering a new avenue for growth in the exploding obesity drug market and a powerful tool to defend its market share. The convenience of a daily pill is expected to attract a new wave of patients who have been hesitant to use the current injectable-only therapies, a phenomenon often referred to as 'needle fatigue.'
Shares of Novo Nordisk jumped in extended trading following the news, building on a regular session close of $48.10. The company, which has seen its market capitalization swell to over $213 billion, is a dominant force in the healthcare sector, largely due to the unprecedented success of its GLP-1 drugs Ozempic and Wegovy.
The FDA's decision was underpinned by strong clinical data from Novo Nordisk's OASIS 4 trial. The study demonstrated that the 25mg oral tablet led to a mean weight loss of 16.6% over 64 weeks, an efficacy profile comparable to its injectable counterpart. This robust performance gives the company a strong clinical foundation as it prepares for a commercial rollout.
This approval intensifies the fierce competition between Novo Nordisk and its primary rival, U.S.-based Eli Lilly (LLY), whose drug Zepbound (tirzepatide) has become a formidable competitor to Wegovy. While Novo Nordisk now has a first-mover advantage in the oral segment, Eli Lilly is advancing its own oral weight-loss candidate, orforglipron, which it expects to launch in 2026.
Novo Nordisk has set an ambitious timeline, planning for a U.S. launch in early January 2026. However, the path to market will be closely watched. The company has grappled with significant manufacturing and supply chain constraints to meet the staggering demand for its injectable drugs, and investors will be looking for assurances that it can produce the new oral formulation at scale.
Analysts are bullish on the pill's prospects. Pre-approval surveys indicated that nearly 90% of primary care physicians would be willing to prescribe the oral version within six months of its launch, according to recent industry analysis. The move could significantly expand the addressable market, which some projections place in the hundreds of billions of dollars. The ease of administration is seen as a key factor in broadening access beyond specialist care and into primary care settings.
Despite the breakthrough, Novo Nordisk faces a complex landscape. The market is bracing for increased competition, not only from Eli Lilly but also from other pharmaceutical players like Pfizer and emerging biotech firms. Furthermore, the specter of Medicare price negotiations and looming patent expirations for its foundational GLP-1 patents remain long-term challenges for the company's flagship franchise.