FDA to weigh up Ocaliva approval amid doubts

Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday.

The panel will review the supplemental new drug application (sNDA) for the 5mg titrated to 10mg oral tablets—administered once a day—submitted by Intercept to fulfil the accelerated approval post-marketing requirements specified by the FDA in 2016.

Intercept’s sNDA included data proposed to describe and verify clinical benefit for the indication of reducing the risk of death, liver transplant, and hepatic decompensation in adults with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.