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Intercept’s CRL Just Continues Upheaval In NASH

 
• By Joseph Haas

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?

Drugs question mark
The NASH competition may be wide-open again

A year of overturned expectations in the non-alcoholic steatohepatitis space continued on 29 June with Intercept Pharmaceuticals Inc.announcing the receipt of a complete response letter from the US Food and Drug Administration for obeticholic acid (OCA), which has had potential to be the first approved NASH drug. One year ago, the general expectation was that Intercept might be headed to market with OCA by now, with Genfit SA on its tail with elafibranor as a strong second-to-market candidate.

Genfit’s aspirations took a possibly mortal blow in May as elafibranor failed its Phase III trial. (Also see "RESOLVE-IT...

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