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Intercept Wins FDA Approval for Drug to Treat Liver Disease

  • Ocaliva will be Intercept’s first product to reach the market
  • Company is also studying the drug in larger NASH market

Intercept Pharmaceuticals Inc. won approval for a drug to treat an uncommon, slow-progressing liver disease called primary biliary cirrhosis, its first product to reach the U.S. market.

The Food and Drug Administration cleared Intercept’s Ocaliva, also known as obeticholic acid, according to a statement from the company on Friday. The agency approved the drug with the condition that Intercept perform further studies to show it reduces patients’ risk of liver transplant and death.