Intercept Gifts Shareholders With NASH Refiling

23 Dec 2022

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

28 May 2025

• By Kevin Grogan

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

26 May 2025

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

22 May 2025

• By Alexandra Shimmings

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.