Intercept Unlikely To Refile OCA For NASH Before Late 2021
Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.
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Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint
Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III
AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.
Akero First To Show Benefit In Cirrhotic NASH Patients
Although the data are from a small cohort of an ongoing study, Akero’s FGF21 analog reduces fibrosis score by at least one stage in 33% of cirrhotic NASH patients.