Posted by Michael Wonder on 28 Apr 2026
GSK’s investigational liver therapy, efimosfermin, receives US FDA breakthrough therapy and EMA Priority Medicines (PRIME) designations for MASH
27 April 2026 - GSK today announced that efimosfermin, a once monthly investigational liver therapy, has been granted breakthrough therapy designation by the US FDA and Priority Medicines (PRIME) Designation by the EMA for the treatment of MASH.
The two designations were supported by data from MASH patients with moderate to advanced (F2/F3) and cirrhotic (F4) fibrosis.
