Intercept Gifts Shareholders With NASH Refiling

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, the Morristown, NJ-based firm has seen a change at the CEO level – with Jerome Durso succeeding Mark Pruzanski – and has refuted speculation multiple times that the company was going to give up on OCA in NASH altogether

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