FDA has delayed the pre-submission meeting regarding the marketing application for Ocaliva in nonalcoholic steatohepatitis.
Intercept Pharmaceuticals, Inc. announced an update on the timing of its pre-submission meeting with the FDA regarding the potential resubmission of its nonalcoholic steatohepatitis (NASH) New Drug Application (NDA) based on an interim analysis of the REGENERATE trial in patients with fibrosis due to NASH.
The pre-submission meeting, previously scheduled in June, has been moved to July following a recent request from the FDA that topline data from REGENERATE be provided to the agency for its review prior to the meeting. Intercept anticipates that topline data from REGENERATE will be available and made public in July.
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