Intercept’s NASH NDA Positions OCA For May 2020 Approval, Then Launch
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.
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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.
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?
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.