Intercept's liver drug gets conditional backing of EMA panel

Reuters Health Information: Intercept's liver drug gets conditional backing of EMA panel

Intercept's liver drug gets conditional backing of EMA panel

Last Updated: 2016-10-14

By Reuters Staff

(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. (http://bit.ly/2dYKT7R)

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.

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