Intercept’s NASH NDA Positions OCA For May 2020 Approval, Then Launch
Executive Summary
Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.
You may also be interested in...
Intercept Unlikely To Refile OCA For NASH Before Late 2021
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.
Akero Histology Data Could Be Best In Class For NASH
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.
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?