European Commission Revokes Ocaliva License in PBC

Advanz has reported the European Commission (EC) has revoked the conditional marketing authorisation of OCALIVA® (obeticholic acid) in Europe for second-line treatment of patients with the rare disease Primary Biliary Cholangitis (PBC).

Advanz is “considering all options to help ensure continued access to OCALIVA®.”

The Company maintains the CHMP recommendation “did not adequately consider the totality of available data supporting the efficacy and safety of OCALIVA® in PBC, in particular the wealth of positive real-world evidence (RWE) gathered from more than seven years of clinical use representing over 47,000 patient-years of treatment experience.”

In a further rebuttal, Advanz claims the CHMP relied mainly on one analysis based on a single, randomised placebo-controlled trial, Study 747-302 (COBALT), which had multiple limitations. These included patients in the “placebo arm unsurprisingly chose to switch to commercially available therapy but were required to be analysed as placebo treated patients under the Intention to Treat methodology.”

OCALIVA® was conditionally approved by the EMA in December 2016.

Notification Link: ADVANZ PHARMA’s response to European Commission revocation of conditional marketing authorisation for OCALIVA® in rare disease Primary Biliary Cholangitis (PBC)