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Bile Acid Synthesis Disorders News

Cholbam Approved for Rare Metabolic Disorders

Posted 23 Mar 2015 by Drugs.com

WEDNESDAY, March 18, 2015 – Cholbam (cholic acid) capsules have been approved by the U.S. Food and Drug Administration to treat adults and children with bile acid synthesis disorders and peroxisomal disorders, the agency said in a news release. People with these rare disorders lack enzymes to process cholic acid, normally made by the liver from cholesterol. This leads to reduced bile flow, potentially poisonous buildup of bile acid products in the liver and less absorption of fats and vitamins. Left untreated, the disorders could cause deadly liver damage, the FDA said. Cholbam is sanctioned for adults and children aged 3 weeks and older. The drug was evaluated in clinical studies involving some 79 people aged 3 weeks to 36 years. Two-thirds of people with bile synthesis disorders treated with the drug survived longer than three years. And 42 percent of people with peroxisomal ... Read more

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Liver and Pancreatic Disease

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Cholbam, cholic acid