FDA advisory committee votes against approval for NASH drug GastroTwitter
OCA, sold under the commercial name Ocaliva, was first approved in 2016 to treat primary biliary, and is prescribed at up to 10 mg per day. Intercept proposed that OCA be given in daily 25-mg doses in the treatment of precirrhotic fibrosis due to NASH.
In 2019, Intercept initially filed for a new drug application for OCA for the treatment of precirrhotic fibrosis due to NASH but were issued a Complete Response Letter after the FDA determined that the medication had an"unfavorable risk benefit-risk assessment." Intercept resubmitted an NDA for OCA in December 2022, including two 18-month analyses from a phase 3 REGENERATE study.
In the study, which included data from 931 patients, OCA 25 mg outperformed placebo in improving fibrosis with no worsening of NASH over 18 months, one of two primary endpoints of the clinical trial. The estimated risk difference ranged from 8.6 to 12.8 across different analyses, which the FDA categorized as a"modest treatment effect."
There was no significant difference between OCA 25 mg and placebo in NASH resolution with no worsening fibrosis. Both endpoints were surrogate endpoints, meaning that they were"reasonably likely to predict clinical benefit." The FDA noted that it is not known if a decrease in fibrosis stage would lead to clinically meaningful outcomes, such as reduction in liver-related events.
The committee members voted 15 to 1 to defer approval until clinical outcome data is submitted and reviewed. The FDA has set a target decision date regarding the accelerated approval of OCA for NASH for June 22, 2023.
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