EMA Backs Novo Nordisk's Wegovy Pill in Boost for Oral Weight-Loss Race

Europe's medicines regulator has recommended approval of Novo Nordisk's (NVO) oral Wegovy, paving the way for the first weight-loss pill to reach the European market and handing the Danish drugmaker a lead over US rival Eli Lilly (LLY).

The European Medicines Agency's positive opinion, now passes to the European Commission for final marketing authorization. Novo plans to launch the pill in select markets outside the United States in the second half of 2026.

The recommendation intensifies an already heated rivalry between Novo and Lilly for dominance in the obesity drug market, which analysts project could exceed $100 billion annually within the next decade as both companies race to expand beyond injectable treatments into more convenient oral formats.

Novo entered the US oral market earlier this year following FDA approval, giving it a head start. Lilly's competing weight-loss pill, Foundayo, launched in the US in April and remains under EMA review in Europe.

The Wegovy pill contains semaglutide, the same active ingredient in Novo's injectable Wegovy and Ozempic franchises. In a late-stage trial spanning 64 weeks, patients taking a 25mg dose lost an average of 16.6% of their body weight, against 2.7% for those on placebo. The EMA noted that a tablet format may offer greater convenience for certain patients.

Unlike Lilly's pill, oral Wegovy must be taken on an empty stomach and separately from other medications. Tricia Tan, professor of metabolic medicine and endocrinology at Imperial College London, said that while the fasting requirement is not a significant hurdle once patients are properly counseled, daily adherence could prove challenging.

Early US prescription data for both oral drugs has bolstered the case that pills can expand the overall market by attracting patients unwilling or unable to use injections.

However, regulatory clearance alone will not ensure broad patient access across Europe. Dr. Anita Phung, research physician at Lindus Health, cautioned that reimbursement policies vary significantly across European countries, and that injectable Wegovy is already frequently restricted to specialist rather than primary care settings on the continent.

The EMA also recommended approval of a 7.2mg single-pen Wegovy dose, which Novo expects to launch in the third quarter.