Posted by Michael Wonder on 15 Dec 2016
European Commission grants Intercept's Ocaliva (obeticholic acid) marketing authorisation for the treatment of primary biliary cholangitis
14 December 2016 - Intercept Pharmaceuticals today announced that the European Commission has granted conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid.
Ocaliva is a potent and selective agonist of the farnesoid X receptor, which is expressed at high levels in the liver and intestine and thought to be a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
