EMA grants conditional approval for biliary cholangitis treatment

pharmafile | October 17, 2016 | News story | Sales and Marketing |  EMA, intercept, ocaliva, primary biliary cholangitis 

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voiced its approval of Intercept’s Ocaliva for primary biliary cholangitis (PBC), on the condition that the drugmaker provides updates on the treatment’s safety and efficacy for the FXR agonist from its ongoing COBALT trial and a short-term study in patients with hepatic impairment.

Ocaliva is cleared to be used in combination with ursodeoxycholic acid (UDCA), currently the only approved medicine for the treatment of PBC, in patients who have not responded to UDCA alone or for whom it is not suitable. The CHMP came to the verdict on the back on data from three trials investigating the use of Ocaliva on alkaline phosphatase and bilirubin levels in PBC sufferers; phase III trials showed the drug to reduce alkaline phosphatase levels by 47% over 12 months compared to 10% for placebo.

Ocaliva was awarded orphan drug designation in 2010, while the FDA gave it accelerated approval for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis last year and in May for treatment of PBC.

Matt Fellows