Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)

Shots: Gilead has reported the P-III (IDEAL) trial data assessing Livdelzi (seladelpar) vs PBO in 96 adults (18-75yrs.) with PBC who have inadequately controlled disease, on or intolerant to ursodeoxycholic acid Trial showed that a higher proportion of pts treated with Livdelzi achieved normalization of ALP after 52wks.; data to be presented at a future conference & discussed…

ByRidhi RastogiJune 3, 2026

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs…

ByDipanshu DixitFebruary 21, 2025

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: The CHMP has recommended Seladelpar + ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or as monotx. in those intolerants to UDCA. The EC’s decision is expected in Q1’25 Opinion was based on a P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC patients (n=193). It showed…

ByDipanshu DixitDecember 13, 2024

Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

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