Intercept Pharma's Chronic Liver Disease Drug Gets Accelerated FDA Approval
Intercept Pharmaceuticals Inc. received accelerated approval from the Food and Drug Administration for its chronic liver disease drug, the FDA said Tuesday morning. The drug, Ocaliva, is intended for adults with primary biliary cholangitis who have an inadequate response to another treatment, ursodeoxycholic acid. Ocaliva works in combination with ursodeoxycholic acid, which is the only other approved treatment for PBC but isn't effective in up to 40% of patients, with 5% to 10% of patients not tolerating the treatment. Intercept shares rose 24.2% in the last three months, compared with a 8.7% rise in the S&P 500 .
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