Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) has a “modest” treatment effect on a surrogate endpoint but poses “substantial” risks in the treatment of nonalcoholic steatohepatitis (NASH) that cannot be readily mitigated, the US Food and Drug Administration said.
Intercept’s OCA In NASH: ‘Modest’ Effect On Surrogate Comes With ‘Substantial’ Risks, US FDA Says
Ahead of advisory committee vote on accelerated approval, agency takes a dim view of obeticholic acid's benefit-risk balance for the treatment of liver fibrosis due to NASH, citing risks of drug-induced liver injury and morbidity associated with biopsies necessary for appropriate patient selection.
More from US FDA Performance Tracker
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
• By
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
More from Regulatory Trackers
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.