FDA curbs use of liver drug Ocaliva on safety concerns

The US Food and Drug Administration announced on Wednesday that it is restricting the use of US biotech firm Intercept Pharmaceuticals’ (Nasdaq: ICPT) liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm.

Intercept saw its shares fall as low as $13.88 in early trading yesterday, but more than recovered, up 10% at $17.05 after the bell.

Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplant. In the five years since Ocaliva’s accelerated approval, the FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated). Many of these PBC patients had advanced cirrhosis before starting Ocaliva.