Bile acid sequestrant

Intercept Announces Updated Ocaliva® (obeticholic acid) U.S. Prescribing Information

Retrieved on: 
Wednesday, May 26, 2021
Medical specialties, Health, Orphan drugs, Cholanes, Obeticholic acid, Hepatology, Health informatics, Medication package insert, Bile acid sequestrant, Cirrhosis

The changes to the Ocaliva Prescribing Information were prompted by cases submitted to FDAs Adverse Event Reporting System and published in the medical literature describing cases of worsening of liver problems or liver failure in PBC patients with cirrhosis treated with Ocaliva.

Key Points: 
  • The changes to the Ocaliva Prescribing Information were prompted by cases submitted to FDAs Adverse Event Reporting System and published in the medical literature describing cases of worsening of liver problems or liver failure in PBC patients with cirrhosis treated with Ocaliva.
  • Intercept is committed to patient safety, and the revised Prescribing Information will provide important guidance to encourage appropriate use of Ocaliva.
  • Intercept is executing a multi-faceted plan to inform healthcare professionals and patients living with PBC about the updated U.S. Prescribing Information to enable appropriate patient treatment consistent with the Ocaliva U.S. Prescribing Information.
  • Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing.

Mirum Pharmaceuticals Announces Data Presented During AASLD Highlighting Durable Improvements in Pruritus and Quality of Life in Children with Alagille Syndrome Treated with Maralixibat

Retrieved on: 
Sunday, November 15, 2020
Health, Consumer, Infectious diseases, Children, Pharmaceutical, Biotechnology, Medical specialties, Hepatology, Branches of biology, Clinical medicine, Digestive system, Bile acid, Enterohepatic circulation, Cholesterol, Bile, Ileal sodium/bile acid cotransporter, Bile acid sequestrant, the ITCH and IMAGINE II study, Alagille Syndrome, Maralixibat, Mirum Pharmaceuticals

Maralixibat, an apical sodium bile acid transporter (ASBT) inhibitor, has previously been shown to interrupt the enterohepatic circulation of bile acids, reducing pruritus .

Key Points: 
  • Maralixibat, an apical sodium bile acid transporter (ASBT) inhibitor, has previously been shown to interrupt the enterohepatic circulation of bile acids, reducing pruritus .
  • Maralixibat treatment improved quality of life and led to improved growth parameters.
  • To view the presentation and the complete data, please visit the AASLD section within the Events page on Mirums website.
  • Children receiving maralixibat in the studies also demonstrated improvements in biomarkers of disease, including reductions in cholesterol and bile acid levels.