NASH Drug Development Questions? US FDA Has Many Of The Answers
From biomarkers to treatment effect size, agency officials respond to some of more than a hundred questions that poured in during a webinar on development of drugs to treat the liver disease.
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Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.
The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.
Analysts say the cirrhosis-reversing benefit seen with Akero’s efruxifermin portends well for the entire class, and that 89bio might differentiate on safety, tolerability and dosing frequency.