With Phase III NASH Endpoints In Place, Intercept May Reach Market By 2018
This article was originally published in The Pink Sheet Daily
Although it is the first company to reach Phase III in non-alcoholic steatohepatitis, Intercept has a long road ahead with a 2,500-patient trial that will include a 72-week interim look that could lead to initial approval in the U.S. and EU.
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Follow-up Phase IIa data shows strong antifibrotic and NASH-resolution effects for Akero’s efruxifermin, an FGF21 analog. Analysts are calling the drug potentially best in class.
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?