Intercept's Ocaliva meets Phase III goal for PBC treatment

Positive results of the pivotal Phase III trial for Intercept Pharmaceutical’s (Nasdaq: ICPT) Ocaliva (obeticholic acid) in patients with primary biliary cholangitis (PBC) have been published in the New England Journal of Medicine (NEJM).

The POISE trial assessed the safety and efficacy of the treatment in PBC patients who had an inadequate therapeutic response to, or were unable to tolerate the current standard of care, ursodeoxycholic (UDCA).

Ocaliva met the primary endpoint of the POISE trial and improved multiple biochemical disease markers as compared to placebo with high statistical significance. The drug was granted accelerated approval by the US Food and Drug Administration in May 2016 and is currently under review by the European Medicines Agency. If approved in Europe, it will be the first treatment made available for patients with PBC in 20 years, thus filling an important unmet need for those patients who have an inadequate response or are intolerant to UDCA.