FDA Support for Obeticholic Acid (OCA)

PBC Colleagues outside FDA Building


UK-PBC team helps new PBC drug to the point of licensing. UK-PBC investigators have been heavily involved in the FDA approval process for Obeticholic Acid, a novel drug for use in PBC patients unresponsive to UDCA.

On Thursday 7th April an independent Advisory Committee voted 17 to 0 to support FDA approval of OCA which will now be the first new drug approved for use in PBC in 20 years. Data from the UK-PBC played a key role in convincing the committee that there is significant unmet need in PBC and thus a need for new drugs.