Will Intercept’s New NASH Analysis Pass FDA’s Muster?
Consensus Method Shows Consistent Efficacy
The new analysis of REGENERATE, based on an FDA-requested methodology, shows continued efficacy for OCA, but analysts were circumspect about whether the benefit/risk profile would sway the agency.
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Dr Reddy’s is the first of six generics firms to challenge Intercept’s Ocaliva patents to reach a settlement, and will be able to market its product in the US from 2035 onward.
Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.
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.