#ICPT reported their Type A Meeting the U.S. Food and Drug Administration regarding Ocaliva for Adult nonalcoholic steatohepatitis (NASH).
“We were pleased to reengage with FDA at our recent Type A end-of-review meeting to discuss the Agency’s benefit-risk assessment in the CRL based on its review of the available data, as well as our proposed way forward to resubmitting our NDA for OCA in NASH fibrosis,” saidMark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The meeting was constructive and FDA has provided us with helpful guidance regarding supplemental data we can provide to further characterize OCA’s efficacy and safety profile that could support resubmission based on our Phase 3 REGENERATE 18-month biopsy data, together with a safety update from our ongoing studies. We are advancing accordingly and plan to hold additional meetings with the Agency with the goal of achieving sufficient alignment to proceed on this basis and potentially resubmit our NDA next year. Of note, the REGENERATE outcomes phase is ongoing and our Phase 3 REVERSE study in NASH patients with compensated cirrhosis is expected to read out by the end of next year. We continue to lead the NASH field and believe that, if approved, OCA has the potential to become an important treatment for patients with advanced fibrosis due to NASH" (see press release HERE).
See our ICPT Ocaliva for NASH AmpCard HERE.