USFDAApr 27, 2026, 08:21 AM
GSK's Efimosfermin Gets US FDA Breakthrough & EMA PRIME for MASH
AI Summary
GSK announced that its investigational liver therapy, efimosfermin, received both US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) designations for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). These designations aim to expedite development and review for serious conditions with significant unmet medical needs, supported by positive Phase II data showing improved liver fibrosis. Efimosfermin is currently in Phase III trials for moderate to advanced fibrosis, with trials for cirrhotic MASH (F4) expected to commence this year.
Key Highlights
- GSK's efimosfermin received US FDA Breakthrough Therapy Designation for MASH.
- Efimosfermin also granted EMA Priority Medicines (PRIME) Designation for MASH.
- Phase II data showed once-monthly efimosfermin improved liver fibrosis in MASH patients.
- MASH is a leading cause of liver transplant in the US and Europe.
- Efimosfermin is currently in Phase III ZENITH-1 and ZENITH-2 trials for F2/F3 fibrosis.
- Phase III trials for F4 fibrosis in MASH patients are expected to start this year.