Intercept Pharmaceuticals Inc said its liver drug received conditional approval from the European Commission to treat patients with primary biliary cholangitis (PBC), a rare liver condition.
Intercept’s shares rose about 4 percent to $113.00 in premarket trading on Wednesday.
The approval came two months after the company’s drug, Ocaliva, received a positive recommendation from an advisory committee.
The U.S. Food and Drug Administration granted an accelerated approval to the drug in May.
When a drugmaker wins accelerated or conditional approval, the company must provide further evidence of the drug’s benefit to satisfy the regulator, failing which the approval can be revoked.
Ocaliva or obeticholic acid is aimed at treating a rare liver condition in which the body mistakes the bile ducts in the liver for foreign objects and tries to destroy their lining.
Intercept is also testing Ocaliva to treat nonalcoholic steatohepatitis, another serious liver disease with no approved treatments and a market potential of $40 billion.
PBC, which causes life-threatening complications, primarily affects about one in 1,000 women over the age of 40, the company said. [nGNXNNMRLa]
Up to Tuesday’s close of $108.53, stock had lost about 27 percent of its value this year.
(Reporting by Natalie Grover and Divya Grover in Bengaluru; Editing by Anil D’Silva and Martina D’Couto)