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GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus Trial met its 1EP & key 2EPs showing…
2 days ago

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Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Shots: Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selection Trial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…
September 1, 2025

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GSK New
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GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…
May 8, 2025

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Gilead (2)
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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…
December 13, 2024

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Gilead (2)
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US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC) 

Shots:     Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis  The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…
August 14, 2024

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Ipsen
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Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC) 

Shots:    The CHMP’s positive opinion of Iqirvo (PPAR agonist) + ursodeoxycholic acid (UDCA) for PBC adults having inadequate UDCA response or Iqirvo alone for UDCA intolerant patients was based on P-III (ELATIVE) study. EC’s decision is anticipated in Q3’24. The company has submitted Iqirvo for PBC to the MHRA    The P-III (ELATIVE) study assessed Iqirvo…
July 26, 2024

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