Posted by Michael Wonder on 10 Dec 2022
Efruxifermin granted FDA breakthrough therapy designation for NASH
8 December 2022 - Designation based on Akero’s Phase 2b HARMONY study finding that both the 50 mg and 28 mg efruxifermin doses achieved statistical significance on primary and secondary histology endpoints after 24 weeks.
Akero Therapeutics today announced that efruxifermin has received a breakthrough therapy designation from the US FDA for the treatment of non-alcoholic steatohepatitis.
