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Intercept Gifts Shareholders With NASH Refiling

 
• By Joseph Haas

Nearly two-and-a-half years after an FDA complete response letter stalled obeticholic acid’s path to the first approval in non-alcoholic steatohepatitis, Intercept refiled its NDA on 23 December.

Second chance
Intercept refiles OCA for NASH 30 months after FDA complete response letter • Source: Shutterstock

Less than a week after Madrigal Pharmaceuticals, Inc. boosted the stagnant non-alcoholic steatohepatitis (NASH) R&D chase with positive Phase III results, Intercept Pharmaceuticals, Inc. added to a sense of momentum with the 23 December announcement that it has refiled its new drug application for its FXR agonist obeticholic acid (OCA) in NASH, culminating a nearly 30-month process of responding to a US Food and Drug Administration complete response letter in June 2020.

Since receiving the CRL in June 2020, which seemed to dash Intercept’s hopes of launching the first NASH drug therapy,...

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