First drug for NASH under second FDA review

Live disease

Intercept Pharmaceuticals’ obeticholic acid (OCA) could be first drug to be approved in the US for non-alcoholic steatohepatitis (NASH), according to analysts GlobalData. 

The Food and Drug Administration (FDA) accepted the company’s resubmission of its new drug application (NDA) for OCA in patients with pre-cirrhotic liver fibrosis due to NASH in December 2022. 

According to GlobalData forecasts, the NASH market will be worth $27.7 billion by 2031. It has the potential to be a large and lucrative therapy market due to the prevalence of the disease and the lack of approved agents. 

Intercept Pharmaceuticals is currently leading the race with its OCA, a Farnesoid X receptor (FXR)agonist, which is currently in a six-month review period. The newly resubmitted NDA is supported by two positive, interim 18-month analyses from the REGENERATE trial.  

Sravani Meka, Senior Immunology Analyst at GlobalData, said: “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.” 

GlobalData predicts the drug has a 64% likelihood of approval when compared to other late-stage assets currently in development for NASH in the US, France, Germany, Italy, Spain, UK and Japan).

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