Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay
The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.
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Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?