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Ocaliva OK'd; Will NASH Success, Acquisition Be Next For Intercept?

Executive Summary

As expected, Intercept Pharmaceuticals Inc. was granted an accelerated approval for Ocaliva (obeticholic acid) as a treatment for primary biliary cholangitis. But the drug's potential in the much more lucrative indication of nonalcoholic steatohepatitis may be what piques the interests of larger pharmaceutical companies for a possible acquisition of the New York-based biotech.

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Positive Panel, But What's Ahead For Intercept's Ocaliva?

After the FDA's glowing review on paper and even more so at the meeting of the agency's Gastrointestinal Drugs Advisory Committee, it was highly likely the panel would back a speedy approval of Intercept Pharmaceuticals Inc.'s Ocaliva (obeticholic acid) as a treatment for primary biliary cholangitis (PBC), a rare and potentially fatal liver disease.

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