Europe’s medicines watchdog has recommended approval of Novo Nordisk’s semaglutide pill for weight loss, making it the first oral GLP-1 drug backed for use on the continent.
The European Medicines Agency’s (EMA) recommendation on Friday clears the path for the once-daily semaglutide tablet to reach European patients, with full approval expected to follow.
Novo launched the pill in the US in January 2026 after winning FDA approval in December 2025, giving it a significant head start in what analysts expect to be a $150bn-a-year market within a decade.
The European green light is a major commercial prize, as the continent represents one of the largest and most lucrative markets for prescription medicines in the world, and demand for effective obesity treatments has surged in recent years.
Trial data
The pill’s approval is backed by data from the OASIS 4 trial, a 64-week phase 3 study in which patients with obesity or overweight lost an average of 16.6% of their body weight while on treatment, a result comparable to Novo’s existing injectable form of the drug. One in three participants lost 20% or more of their body weight.
The pill works by mimicking a gut hormone that curbs hunger and slows digestion. Crucially, side effects were broadly in line with those seen in earlier semaglutide trials, with nausea, diarrhoea and vomiting the most commonly reported.
The competition
Lilly’s rival oral pill, orforglipron, won FDA approval in April 2026 and is now available in the US. Lilly argues its drug holds a practical edge, as unlike the semaglutide pill, which must be taken first thing in the morning on an empty stomach, orforglipron can be taken at any time of day without food or water restrictions. Lilly has not yet filed for European approval, leaving Novo with a clear runway on the continent for now.
Both pills are priced at $149 a month for cash-paying patients in the US.
The oral drug race marks a new front in the obesity treatment space, which has to date been dominated by weekly injections, and is expected to significantly widen the pool of patients willing to seek treatment.
Featured image: Jo Panuwat D on Adobe Stock
