(Reuters) -The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals’ liver disease drug, raising questions about its future in the market.
The drug, Ocaliva, will continue to be available in the U.S. under the accelerated approval status, the company said.
Ocaliva received the FDA’s accelerated approval in 2016 to treat patients with primary biliary cholangitis, a rare disease that causes inflammation of small bile ducts in the liver and can eventually destroy them.
The health regulator’s decision on Tuesday is in line with the recommendation of a panel of independent experts in September.
The panel said available data does not clearly prove the drug’s effectiveness or remove doubts about its safety. The panel voted 10-1 against full approval of the drug.
(Reporting by Puyaan Singh and Bhanvi Satija in Bengaluru; Editing by Sriraj Kalluvila)
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