United States-based Akero Therapeutics Inc. (Nasdaq: AKRO), has received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for efruxifermin (EFX), an investigational FGF21 analogue, intended for the treatment of non-alcoholic steatohepatitis (NASH), a non-alcoholic fatty liver disease, it was reported on Friday.
The product was granted the designation based on the positive efficacy data recently reported from the company's Phase 2a BALANCED study.
The firm is planning to start a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed NASH patients in the first half of 2021, based on guidance received from the United States Food and Drug Administration (FDA).
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