The new treatment is called Ocaliva. The obeticholic acid medication is administered orally and increases bile flow from the liver while suppressing acid production. This works to reduce the organ’s exposure to toxic levels of bile acid.
The treatment could fill some care gaps for PBC patients who have not responded to ursodeoxycholic acid — a previously approved treatment for the condition.
Amy Egan, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, “Patients left untreated, or who have not responded to UDCA, are at risk for liver failure and death…today’s approval of Ocaliva provides an important treatment option for patients living with PBC who have not responded to the only other approved therapy, UDCA.”
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