Intercept Pharmaceuticals’ obeticholic acid could be first drug to be approved for NASH, says GlobalData

Intercept Pharmaceuticals’ obeticholic acid could be first drug to be approved for NASH, says GlobalData

Following FDA’s acceptance for Intercept Pharmaceuticals’ resubmission of its new drug application (NDA) for obeticholic acid (OCA) in patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH) in December 2022

Sravani Meka, Senior Immunology Analyst at GlobalData, a leading data and analytics company, offers her view:

“NASH has the potential to be a large and lucrative therapy market owing to the prevalence of the disease and the lack of approved agents. According to GlobalData forecasts, the NASH market will be worth $27.7 billion by 2031. Leading the race to commercialize potentially the first-to-market therapy is Intercept Pharmaceuticals, with its OCA, an Farnesoid X receptor (FXR)agonist, as a Class 2 resubmission, which has a 6-month review period.

“The newly resubmitted NDA is supported by two positive, interim 18-month analyses from the REGENERATE trial and a detailed analysis of the largest safety database in NASH demonstrating a solid safety and tolerability profile for the long-term use of OCA. Although the resubmitted NDA has been accepted by FDA this time around, it comes after negative topline results from the company’s Phase III REVERSE trial (NCT03439254) evaluating OCA in patients with compensated cirrhosis due to NASH.

“While Intercept remains confident that the disappointing topline results from REVERSE will not affect its OCA NDA in pre-cirrhotic liver fibrosis due to NASH, it is possible that FDA may request an advisory committee meeting for the application closer to spring 2023 with requests to see additional data of OCA’s efficacy and safety data from REGENERATE and a more detailed review of the failed safety data from REVERSE.

“Therefore, according to GlobalData’s Pharmaceutical Intelligence Centre, as of now, OCA has a 64% likelihood of approval (LOA) as shown in the below chart which displays drug-specific LOA of late-stage assets currently in development for NASH in the 7MM (US, France, Germany, Italy, Spain, UK, Japan). If approved, OCA will be the first drug to enter the market for the treatment of NAFLD/NASH in the US. However, given FDA’s previous actions, it would not be surprising if the agency once again delays the approval of Intercept’s OCA to ensure the positive benefit-risk profile of OCA in the long-term.”

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