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Intercept's liver drug gets conditional backing of EMA panel
October 14, 2016 / 11:37 AM / a year ago

Intercept's liver drug gets conditional backing of EMA panel

(Reuters) - Drugmaker Intercept Pharmaceuticals Inc’s drug to treat a rare liver condition was conditionally approved an advisory committee to the European Medicines Agency on Friday.

The company's obeticholic acid, or Ocaliva, is aimed at patients with primary biliary cholangitis, a condition in which the body mistakes the bile ducts in the liver for foreign objects and tries to destroy their lining. (

The U.S. Food and Drug Administration approved the drug in May to treat the disease.

The EMA grants conditional approval for drugs that fill an unmet medical need for serious conditions and show early evidence of clinical benefits outweighing the risks.

Intercept is also testing obeticholic acid to treat nonalcoholic steatohepatitis, another serious liver disease with no approved treatments and a much bigger opportunity for the company.

The company’s shares were up 1.3 percent at $146 in premarket trade.

Reporting by Mamidipudi Soumithri and Rahul B in Bengaluru; Editing by Sriraj Kalluvila

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