WS Investor
27 Apr 2026, 14:33
GSK announced that its investigational liver therapy efimosfermin has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The designations are based on Phase II data showing that once-monthly efimosfermin significantly improved liver fibrosis and helped resolve MASH in patients with moderate to advanced disease, compared to placebo. The therapy also demonstrated a favorable safety profile, with mostly mild and temporary side effects.
MASH, affecting up to 5% of the global population, is a major cause of liver transplants, with limited treatment options currently available—particularly for advanced stages. Efimosfermin is now advancing into Phase III trials, targeting both moderate and severe fibrosis cases, including cirrhosis.
The designations are based on Phase II data showing that once-monthly efimosfermin significantly improved liver fibrosis and helped resolve MASH in patients with moderate to advanced disease, compared to placebo. The therapy also demonstrated a favorable safety profile, with mostly mild and temporary side effects.
MASH, affecting up to 5% of the global population, is a major cause of liver transplants, with limited treatment options currently available—particularly for advanced stages. Efimosfermin is now advancing into Phase III trials, targeting both moderate and severe fibrosis cases, including cirrhosis.
