89bio Aligns with FDA, EMA on Phase 3 Program for Pegozafermin in NASH

 —Alignment reached on key elements of the NASH development strategy, including accelerated approval pathway for both F4 and F2-F3 NASH patients using histology—

—Outcomes trial in F4 cirrhotic NASH patients expected to support full approval across F2-F4 NASH; potential to accelerate timeline to outcomes readout based on agreement with FDA on modified definition of some events—

—Safety database will be inclusive of data from the ongoing SHTG Phase 3 program—

—Trials to include patients on background GLP-1 therapy to assess potential of combination with pegozafermin—

https://www.biospace.com/article/releases/89bio-reaches-alignment-with-the-fda-and-ema-on-phase-3-program-for-pegozafermin-in-nonalcoholic-steatohepatitis-nash-program-initiation-planned-in-the-first-half-of-2024/