MHRA grants conditional approval for Wegovy to treat MASH with fibrosis; NHS access awaits NICE review

The U.K. medicines regulator has conditionally approved Novo Nordisk’s semaglutide injection, Wegovy, to treat adults with metabolic-associated steatohepatitis, or MASH, and moderate-to-advanced liver fibrosis, a form of scarring. But patients cannot yet get the drug on the National Health Service for that use, because the National Institute for Health and Care Excellence is still assessing whether it is clinically and cost effective.

The Medicines and Healthcare products Regulatory Agency, or MHRA, said Friday that it approved semaglutide for adults with MASH and moderate-to-advanced liver fibrosis on July 3. Novo Nordisk is the marketing authorization holder. The decision is a conditional marketing authorization rather than a full approval, with the agency saying the license was granted on condition that further results from an ongoing study in adults with MASH and moderate-to-advanced liver scarring are submitted. The MHRA said further confirmatory evidence is needed before a full marketing authorization can be issued and that it will review new information at least annually.

The approval rests on results from Part 1 of the phase 3 ESSENCE trial, a 72-week biopsy-based histology readout published in the New England Journal of Medicine in April 2025. In that analysis, 62.9% of patients treated with semaglutide achieved resolution of steatohepatitis with no worsening of fibrosis, compared with 34.3% of patients given placebo. The trial also found a statistically significant improvement in liver fibrosis without worsening steatohepatitis. The longer-running ESSENCE study is continuing, with regulators waiting for data on whether treatment improves major clinical outcomes such as progression of liver disease.

MASH with fibrosis matters clinically because it means patients already have liver scarring, and there have been few approved drug options for the condition. Wegovy is already widely known as a GLP-1 medicine, which helps explain the public attention around the decision, but the MHRA stressed that it remains a prescription-only treatment. “The available evidence indicates that semaglutide is a safe and effective treatment option for patients with MASH. As with all GLP-1 receptor agonists, this is a prescription-only medication and should only be taken in consultation with a doctor,” Julian Beach, the MHRA’s executive director of healthcare quality and access, said in a statement. The agency said the most common side effects are gastrointestinal, including nausea, diarrhea, constipation and vomiting.

The U.K. decision follows moves by other major regulators. The U.S. Food and Drug Administration granted accelerated approval for semaglutide in this setting in August 2025, and the European Commission granted a conditional marketing authorization in March 2026 after a positive opinion from the European Medicines Agency. Semaglutide is the first GLP-1 receptor agonist approved specifically for MASH with fibrosis.

For U.K. patients, though, the practical picture has not changed yet. The MHRA said explicitly that patients with MASH are not currently able to get semaglutide for this condition on the NHS. That will depend on the outcome of NICE’s appraisal, while fuller regulatory approval will depend on confirmatory results from the ongoing ESSENCE trial.