Another milestone for patients with primary biliary cholangitis (PBC) — Gilead’s Livdelzi® (seladelpar) has received accelerated FDA approval as a second-line treatment for PBC.
Kris Kowdley, MD, AGAF, FAASLD, FACP, FAC, was an author of the Phase 3 trial results published in the New England Journal of Medicine. Congratulations to Gilead, Dr. Kowdley, the team in Seattle, and the patients who supported the Phase 3 trial and ongoing research on seladelpar and PBC.
Dr. Kowdley also made substantial contributions to the clinical research program that led to the accelerated FDA approval of Ipsen’s Iqirvo, a PBC treatment approved in June.
Read the full press release: https://www.gilead.com/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-seladelpar-granted-accelerated-approval-for-primary-biliary-cholangitis-by-us-fda
