Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that it has received Breakthrough Therapy Designation from the US Food and Drug Administration, as well as Priority Medicines (PRIME) designation from the European Medicines Agency, for its investigational liver therapy efimosfermin for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

The designations are supported by Phase II data demonstrating that once-monthly efimosfermin improved liver fibrosis and achieved MASH resolution in patients with moderate to advanced disease, while maintaining a favourable safety profile. The therapy is currently being evaluated in Phase III trials, with further studies in cirrhotic patients expected to begin later this year.

GSK said the regulatory designations recognise the potential of efimosfermin to address a significant unmet medical need in MASH, a chronic liver disease affecting up to 5% of the global population and a leading cause of liver transplants in the US and Europe.

Efimosfermin is a long-acting FGF21-based therapy designed to target metabolic pathways linked to liver fat, inflammation and fibrosis. The company said the milestone reflects continued progress in its hepatology pipeline as it advances treatments for chronic liver diseases.