AKRO - EMA grants PRIME designation to Akero Therapeutics' efruxifermin

The European Medicines Agency ((EMA)) has granted Priority Medicines ((PRIME)) designation to Akero Therapeutics' (AKRO) efruxifermin ((EFX)), an investigational FGF21 analog for the treatment of non-alcoholic steatohepatitis ((NASH)).PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application. Also, the EMA's Committee on Human Medicinal Products ((CHMP)) indicated preliminary 16-week data from Akero's Phase 2a trial, the BALANCED study of EFX in biopsy-confirmed NASH patients.The CHMP also expressed that the totality of data, including histology data as well as biomarker data, together with better glycemic control and amelioration of dyslipidemia, suggest potential benefit not only for treatment of NASH but also the broader context of metabolic syndrome common in NASH patients. The company plans to initiate a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed NASH patients in H1 2021.

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EMA grants PRIME designation to Akero Therapeutics' efruxifermin