Intercept Pharma ends investment in development of obeticholic acid for nonalcoholic steatohepatitis (NASH).
Intercept Pharmaceuticals is halting investment its drug development program for nonalcoholic steatohepatitis, or NASH, after receiving negative feedback on its market application for its NASH drug candidate obeticholic acid.
The biotech company said that the FDA concluded after a review the application that it could not be approved in its present form. Intercept added that the company would have to successfully complete a long-term outcomes phase for its Phase III study for the drug, at minimum, for it to be approved. Intercept had been seeking to have the product approved for the treatment of pre-cirrhotic fibrosis due to NASH.
As a result of the FDA's feedback, Intercept said it was ending all further investment in its NASH program and restructuring its operations to focus on rare and serious liver diseases. It added that it plans to "drive an accelerated plan to profitability beginning in 2024."
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