The Food and Drug Administration (FDA) has granted approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (CBP).
Obeticholic acid approved for the treatment of chronic liver disease
primary biliary cholangitis is a rare chronic liver disease in the bile ducts in the liver become inflamed causing the accumulation of bile, leading to liver scarring or cirrhosis.
“The Food and Drug Administration granted accelerated approval of Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (CBP). “
The only approved treatment for CBP was ursodeoxycholic acid (UDCA) and patients who respond inadequately to this treatment can be used in combination with UDCA Ocaliva.
Ocaliva interacts with the farnesoid X receptor (FXR), which plays a key role in regulating bile acid. By binding to this receptor suppresses accumulation Oclavia bile flow and increases, leading to a reduction in liver bile levels.
The drug was tested on 216 participants, which after a year of follow-up, reductions in bile levels were higher in participants treated with Ocaliva compared with those treated with placebo.
Some of the side effects of Ocaliva include fatigue, abdominal pain, sore throat, dizziness and itching of the skin. Ocaliva is manufactured by the pharmaceutical Intercept based in New York.
This article was originally published on medindia.net
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