Two years after CRL, Intercept will meet with FDA later this month to discuss new analysis of NASH drug
Intercept Pharmaceuticals is meeting with the FDA later this month in the biotech’s bid to resubmit its drug, obeticholic acid or OCA, for liver scarring due to NASH.
The FDA rejected the drug in June 2020 after mixed Phase III results, but Intercept said Thursday it has taken a new look at the ongoing late-stage study and the biotech thinks it has the data to support a second shot. In the new analysis of the Phase III study, Intercept once again touted a primary endpoint win in the high-dose 25 mg group, which comprised 308 of the 931 overall patients.
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