Accelerated FDA approval for Gilead’s Livdelzi in PBC
The US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare liver disease, Gilead Sciences (Nasdaq: GILD) revealed yesterday.
The drug is authorized in combination with ursodeoxycholic acid (UDCA) for adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
Gilead gained rights to the drug along with its $4.3 billion buy of CymaBay earlier this year, and noted that Livdelzi is the first and only treatment to demonstrate statistically-significant reductions across key biomarkers, alkaline phosphatase (ALP) normalization and pruritus versus placebo.
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