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Seladelpar improves symptoms of primary biliary cholangitis

1. In this randomized controlled trial, among patients with primary biliary cholangitis (PBC) who had had inadequate response to ursodeoxycholic acid, seladelpar was superior to placebo in achieving biochemical response and symptomatic management. 2. Seladelpar had an acceptable safety profile, with similar rates of adverse events to a placebo. Evidence Rating Level: 1 (Excellent) Study ....

Minute Medicine Inc , Rating Level , Confidence Interval , Chronic Disease , Primary Biliary Cholangitis , Ursodeoxycholic Acid ,

#VisualAbstract: Seladelpar for the treatment of primary biliary cholangitis

Click here to read this study in NEJM. ©2024 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc. ....

Minute Medicine Inc , Alkaline Phosphatase , Bile Duct , Ppar Agonist , Ppard Agonist , Primary Biliary Cholangitis ,

RESPONSE: Seladelpar Normalizes Alkaline Phosphatase, Reduces Pruritus in PBC

Results from the phase 3 trial showed seladelpar elicited biochemical response, normalized alkaline phosphatase, and reduced pruritus at a greater rate than placebo. ....

David Assis , Terry Horner , Gideon Hirschfield , Yale School Of Medicine , Autoimmune Liver Disease Research , Drug Administration , University Of Toronto , Foundation Gideon Hirschfield , New England Journal , Yale School , Cymabay Therapeutic New Drug Application , Priority Review , Prescription Drug User Fee Act , Terry Horner Chair , Primary Biliary , Improves Markers , Second Line Treatment , Primary Biliary Cholangitis , Biochemical Response , Alkaline Phosphatase , Ursodeoxycholic Acid , Obeticholic Acid ,

Itch a wrap: Cymabay PBC story ends with $4.3B Gilead buy

Seeking to rejuvenate itself after recent disappointments, Gilead Sciences Inc. proposes to bolster its liver portfolio by taking over Cymabay Therapeutics Inc. for $32.50 per share in cash, a total equity value of $4.3 billion. The arrangement brings aboard seladelpar for second-line primary biliary cholangitis (PBC) including pruritis (itch), which is under priority review by the U.S. FDA, with a decision due this year. ....

Gilead Sciences Inc , Cymabay Therapeutics Inc , Gilead Sciences , Cymabay Therapeutics , Gilead Sciences Inc , Cymabay Therapeutics Inc , Primary Biliary Cholangitis , Deals Andm Amp A ,

Seladelpar Reduces Serum IL-31, Improves Pruritus in Patients with Primary Biliary Cholangitis

The post-hoc analysis of the phase 3 ENHANCE study provides the first published evidence of a correlation between decreases in IL-31, bile acids, and pruritus symptoms in PBC following treatment with an investigational agent. ....

Researchgate Andreas Kremer , Cymabay Seladelpar , Drug Administration , University Hospital Zurich , Andreas Kremer , Bay Therapeutics , Breakthrough Therapy Designation , New Drug Application , Priority Review , Pruritis Improvement , Primary Biliary Cholangitis , Hoc Analysis , Primary Biliary , Interleukin 31 , Il 31 , Bile Acid ,