Roche (RHHBY.US) plans to include MASH new drug in breakthrough therapy

On May 25th, the CDE website showed that Roche's Pegozafermin is proposed to be included in groundbreaking therapy for the treatment of metabolic dysfunction-associated fatty liver disease (MASH). Pegozafermin is an FGF21 analog developed by 89bio, with both anti-fibrotic and anti-inflammatory effects. In September 2025, Roche acquired 89bio for a total transaction value of 3.5 billion US dollars, gaining ownership of the drug. The results of the phase II ENLIVEN study showed that in the MASH population with stage 2 or 3 fibrosis, the proportion of patients in the Pegozafermin group achieving at least a one-stage improvement in fibrosis without MASH worsening was higher than that in the placebo group. Specifically, the proportions of patients achieving this endpoint in the 15mg group, 30mg group, 44mg group, and placebo group were 22%, 26%, 27%, and 7% respectively. Additionally, the proportions of patients achieving MASH resolution in the 15mg group, 30mg group, 44mg group, and placebo group were 37%, 23%, 26%, and 2% respectively.