Clinical

FDA Says “No” to Intercept Pharma's NASH Drug, Asks for More Data

6 days ago   |   By Xconomy

The FDA has rejected an Intercept Pharmaceuticals drug developed to treat the fatty liver disorder nonalcoholic steatohepatitis, more commonly referred to as “NASH.” New York-based Intercept said Monday that the agency's complete response letter for obeticholic acid stated that its review found that the investigational NASH drug's benefit “remains uncertain” and does not sufficiently outweigh its potential risks. The agency recommended that the company submit more safety and efficacy data from an ongoing clinical study, and continue its long-term evaluation of the drug in NASH patients...
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