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'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim

By determining a safe dosing regimen for Child-Pugh B and C patients, FDA was able to provide a label almost completely without contraindications despite safety concerns about liver-related adverse reactions.

The label for Intercept Pharmaceuticals Inc.'s Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) appears surprisingly clean, allowing broad applicability across an underserved patient population – and smoothing the way for potential expansion into a more lucrative one.

FDA's approval for Ocaliva in PBC, a chronic condition characterized by inflamed, damaged and ultimately destroyed small bile ducts in the liver, is generally seen as a stalking horse for a potential second approval

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