Brand Name
Ocaliva
Generic Name
Obeticholic
View Brand Information FDA approval date: May 27, 2016
Classification: Farnesoid X Receptor Agonist
Form: Tablet
What is Ocaliva (Obeticholic)?
OCALIVA ® is indicated for the treatment of adult patients with primary biliary cholangitis without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase . An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OCALIVA, a farnesoid X receptor agonist, is indicated for the treatment of adult patients with primary biliary cholangitis without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase . An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Approved To Treat
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