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Primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, is an autoimmune disease of the liver. [ 1 ] [ 2 ] [ 3 ] It results from a slow, progressive destruction of the small bile ducts of the liver, causing bile and other toxins to build up in the liver, a condition called cholestasis .
Seladelpar, sold under the brand name Livdelzi, is a medication used for the treatment of primary biliary cholangitis. [1] It is used as the lysine dihydrate salt. [1] It is a peroxisome proliferator-activated receptor delta (PPARδ) receptor agonist. [1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4]
Obeticholic acid (OCA), sold under the brand name Ocaliva, is a semi-synthetic bile acid analogue which has the chemical structure 6α-ethyl-chenodeoxycholic acid.It is used as a medication used to treat primary biliary cholangitis.
In 2019, the US Food and Drug Administration (FDA) granted elafibranor breakthrough therapy designation, based on phase II data, for the treatment of primary biliary cholangitis in adults 18 and older with inadequate response to ursodeoxycholic acid (UDCA). [12] The designation was granted to Genfit. [12]
Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company incorporated in 2002, focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases, such as primary biliary cirrhosis (PBC) now called primary biliary cholangitis, non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary ...
UDCA is used as therapy in primary biliary cholangitis (PBC; previously known as primary biliary cirrhosis) where it can produce an improvement in biomarkers. [14] Meta-analyses have borne out conflicting results on the mortality benefit. [15]
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For patients with primary biliary cholangitis, current guidelines recommend about 13–15 mg/kg of ursodeoxycholic acid as a first line treatment. [121] This drug stimulates biliary bicarbonate secretion, improves survival without having to resort to a liver transplantation, and is very well tolerated—making it an ideal treatment. [ 122 ]
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