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

 
• By Joseph Haas

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.

Busy-City
The busy pace continues in NASH as Intercept files an NDA; Galmed moves into Phase III

Intercept Pharmaceuticals Inc. continues to set milestones in non-alcoholic steatohepatitis (NASH), as the first company to produce successful Phase III data in the disease became the first to seek approval for a NASH therapy, filing a new drug application (NDA) for obeticholic acid (OCA) with the US Food and Drug Administration on 27 September, possibly setting up an approval date of 27 May, 2020.

In announcing the filing, Intercept said it will seek an indication for treatment of fibrosis due to NASH and is seeking a six-month priority review. The drug, a farnesoid X receptor (FXR) agonist, has FDA breakthrough therapy designation for that indication

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