FDApatient focused drug developmentnonalcoholic fatty liver diseasenonalcoholic steatohepatitisNASHNonalcoholic fatty liver disease is a growing public health crisis, with phenotypes from nonalcoholic fatty liver to nonalcoholic steatohepatitis, currently known as NASH, which can progress to liver fibrosis ...
A decade ago, Sanyal helped establish the scientific foundation for what may soon become the first approved drug therapy for NASH at the VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research, where he serves as education core director. Thescientific understandingof howbile...
Intercept公司开发的OCA是一款法尼醇X受体(farnesoid X receptor, FXR)激动剂,而FXR参与胆酸代谢和胆固醇代谢等重要代谢过程。由于在肝脏纤维化NASH患者身上展现出的治疗潜力,它也曾获得美国FDA授予的突破性疗法认定。 本次临床试验的结果进一步证实了这一潜力。在这项随机双盲、含安慰剂对照的多中心试验中,931名出现2...
Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy. The accelerated approval of Rezdiffra is a culmination of more than 15 ye...
Drug Development Historic Approval for MASH, CAR-Ts in the Spotlight The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year. March 19, 2024· 1...
but the FDA has set a high bar. This week, the agency declined to approve Intercept Pharmaceuticals’ obeticholic acid (Ocaliva),as recommended by an advisory committeein May, citing safety concerns related to drug-induced liver injury. Intercept announced thatit will abandon its work on NASH. ...
FDA approves first interchangeable biosimilar insulin The FDA approved the first interchangeable biosimilar insulin product to improve glycemic control for children and adults with diabetes, part of an effort to provide cost-effective options, according to an agency press release.Read more....
Its leading drug, Ocaliva (obeticholic acid) was approved by the FDA to primary biliary cirrhosis (PBC) in 2016, and recently was sold to Advanz Pharma to commercialize Ocaliva outside of the US for $405 million upfront. Regarding NASH, Intercept has an ongoing Phase 3 trial of OCALIVA to...
during Phase 2b and Phase 3 trials, and some molecules are currently under evaluation in various phases of clinical development, regulatory agencies (FDA and EMA) have not yet approved a drug for the treatment of NASH, which still represents a major clinical challenge (Pearlman and Loomba, 2014...
The FDA approved resmetirom under theaccelerated approvalpathway. Thus, the approval hinges on the weight of a surrogate or intermediate clinical endpoint that isreasonablylikely to predict clinical benefit. Notably, the required study will assess clinical benefit after 54 months of treatment. Resmeti...