FDA approves Gileads Liver Drug Livdelzi (Seladelpar) for PBC

Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune disease of the bile ducts. PBC can cause liver damage and possible liver failure if untreated. The disease currently has no cure.

(FDA) granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA), or as monotherapy. FDA’s Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and address unmet medical needs. It’s based on a surrogate endpoint – a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies continue studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

The FDA approved Livdelzi under accelerated approval based on a reduction of ALP. Treatment with Livdelzi led to normalization of alkaline phosphatase (ALP) values, a cholestatic marker that is a predictor of risk for liver transplant and death, in 25% of trial participants at month 12, This change was not seen in any trial participants receiving placebo, as per press release by Gilead.

LIVDELZI® (seladelpar) 10mg capsules, has a recommended dosage of 10 mg orally once daily.

Gilead Press Release