Key Summary
- Semaglutide has been approved to treat MASH on the condition that further results from an ongoing study on MASH and liver scarring will be submitted.
- The product has a conditional marketing authorisation because further confirmatory evidence is required before a full marketing authorisation can be issued.
- This treatment is currently unavailable on the NHS as NICE is currently evaluating its clinical and cost-effectiveness.
Novo Nordisk's Wegovy (semaglutide) injection has got Medicines and Healthcare products Regulatory Agency's (MHRA) conditional approval to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis (scar tissue in the liver).
MASH develops when excess fat in the liver causes inflammation and scarring. Those who have obesity, type 2 diabetes, or high blood lipid levels are more prone to develop this ailment.
Semaglutide has been approved to treat MASH on the condition that further results from an ongoing study in adults with MASH and moderate to advanced liver scarring will be submitted.
The product has a conditional marketing authorisation because further confirmatory evidence is required of its efficacy and safety as a treatment for MASH before a full marketing authorisation can be issued.
The MHRA will review new information on this medicine at least every year and the Summary of Product Characteristics will be updated, as necessary.
MHRA executive director of Healthcare Quality and Access Julian Beach said, “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.”
The starting dose of 0.25 mg semaglutide once weekly is increased to 0.5mg, 1mg, 1.7mg, with four weeks on each dose, up to the weekly maintenance dose of 2.4 mg.
For patients with obesity (a BMI over 30), the dose can be increased to 7.2 mg once weekly after a minimum of 4 weeks on the 2.4 mg dose.
This treatment is currently unavailable on the NHS as the National Institute for Health and Care Excellence (NICE) is currently evaluating its clinical and cost-effectiveness as a treatment option for MASH.
The Wegovy injection already has authorisations for weight management in adults and adolescents and for the reduction of cardiovascular events in adults.
This approval comes close on the heels of MHRA's nod for Wegovy tablets for weight management.
