Intercept’s CRL Just Continues Upheaval In NASH
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?
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With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.
Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.
Recent development upheaval in non-alcoholic steatohepatitis has created opportunity for new approaches, and Poxel thinks its AMPK activator may address several NASH-related pathologies.