89bio, Inc. announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with MASH. The PRIME status was supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4). The PRIME status is granted by the EMA to provide early and proactive support to developers of promising medicines that, based on clinical data, may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.

PRIME aims to provide multiple benefits so that these medicines can reach patients earlier including, enhanced interaction and early dialogue with EMA, guidance on the overall development plan and regulatory strategy, and the potential for accelerated assessment of the time of marketing authorization application.