The FDA recently approved an ORAL therapy, Livdelzi (seladelpar) from Gilead Sciences, Inc., for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans, primarily women, and is known to cause liver damage and, ultimately, liver failure if untreated. The disease currently has no cure.
Common symptoms include incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night.
Gilead confirmed a list price of $12,606 for 30 tablets (10-mg) which works out to $151,272 per year.
Gilead also confirmed that oral Livdelzi will be distributed through specialty pharmacy.
CLICK HERE to access prescribing information
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Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA
First and Only Treatment to Demonstrate Statistically Significant Reductions Across Key Biomarkers, ALP Normalization and Pruritus Versus Placebo –
