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Autoimmune/Cholestatic/Biliary Diseases News
FDA advisory panel votes against Ocaliva for PBC citing ‘concern for real possible harm’
An FDA advisory committee voted against approval for obeticholic acid in primary biliary cholangitis without cirrhosis or compensated cirrhosis with portal hypertension, citing “concern for real possible harm”.
FDA approves Gilead’s Livdelzi for treatment of primary biliary cholangitis
Gilead’s Livdelzi, a selective peroxisome proliferator-activated receptor delta agonist, has received accelerated FDA approval for the treatment of primary biliary cholangitis, according to a company release.
FDA expands Livmarli approval for pruritus in PFIC to infants as young as 12 months
The FDA has updated the label indication for Livmarli for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis, expanding the patient population to include infants aged 12 months and older.
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Maralixibat improves pruritis, reduces total serum bile acids in all PFIC subtypes
Maralixibat improved cholestatic pruritis and reduced serum bile acids in pediatric patients with progressive familial intrahepatic cholestasis, regardless of disease genotype, according to data from the MARCH-PFIC trial.
Phase 2b interim data: Volixibat ‘potential future option’ for PBC, PSC
Interim analyses of two phase 2b studies of volixibat support its use as potential treatment for patients with primary biliary cholangitis and primary sclerosing cholangitis, according to a press release from Mirum Pharmaceuticals.
VIDEO: Larsucosterol reduces mortality by more than 50% in alcohol-associated hepatitis
In a Healio video exclusive, Mitchell L. Shiffman, MD, reports that U.S. patients with severe alcohol-associated hepatitis treated with larsucosterol experienced a “statistically significant” reduction in 90-day mortality — more than 50%.
FDA approves Ipsen’s Iqirvo ‘to address unmet need’ in primary biliary cholangitis
The FDA granted accelerated approval to Ipsen Pharma’s Iqirvo 80 mg, a first-in-class oral, once-daily peroxisome proliferator-activated receptor agonist for the treatment of primary biliary cholangitis, according to a company release.
‘Substantial proportion’ of PSC patients listed for LT due to dysplasia have no neoplasia
Researchers identified bile duct dysplasia or cancer in most explanted livers with an indication of biliary dysplasia, although as many as 41% had no signs of neoplasia, according to a study of patients with primary sclerosing cholangitis.
Elafibranor has ‘significant, sustained treatment benefit’ in PBC through 78 weeks
Elafibranor sustained biochemical response through week 78 in patients with primary biliary cholangitis and has a “potential beneficial effect” on itch-related quality of life, according to late-breaking data presented at EASL Congress.
‘Sustained improvement’ in markers of liver injury, pruritis with seladelpar in PBC
WASHINGTON — Seladelpar use led to “rapid, marked and sustained improvement” in markers of cholestasis and liver injury among patients with primary biliary cholangitis, according to interim results of the ongoing, phase 3 ASSURE study.
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Headline News
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Over one-third of adults not planning on receiving recommended vaccines this fall
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Popular home BP devices unable to provide accurate readings for millions due to sizing
September 19, 20242 min read
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Headline News
Burnout, withdrawal remain ‘alarmingly high’ among physicians and residents
September 17, 20242 min read -
Headline News
Over one-third of adults not planning on receiving recommended vaccines this fall
September 18, 20242 min read -
Headline News
Popular home BP devices unable to provide accurate readings for millions due to sizing
September 19, 20242 min read