Its lead liver asset, obeticholic acid, was pushed for NASH (MASH's old name) and was rejected by the FDA twice despite producing statistically significant fibrosis data, because the agency wasn't satisfied on the totality of benefit-versus-risk

DOI: Published online: July 24, 2025 1 Institute of Medical Research, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea 2 Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Correspondence to Seok-Woo Hong, PhD Institute of Medical Research, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea Email: [email protected] Won-Young Lee, MD Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea Email: [email protected] *Jinmi Lee and Eun-Jung Rhee contributed equally to this work as co-first authors
Group differences were assessed using one-way ANOVA ( n = 10 Fed, n = 6 LiCl, n = 9 Lira, n = 9 Dan, n = 10 Orfo
RCT (759)