FDA adds new 'do not use' note to Intercept's Ocaliva label after a slew of side effect reports in cirrhosis patients
Intercept has seen nothing but hard times the past year after a highly touted swing at NASH fell flat at the FDA’s feet last summer. Now, the drug that Intercept hoped would get over the finish line in NASH is facing new safety flags in another indication, and the FDA is taking action on its label.
The FDA has added a contraindication to its label for Intercept’s Ocaliva (obeticholic acid) to treat primary biliary cholangitis after a slew of side effects in patients with advanced cirrhosis and early cirrhosis patients with existing hypertension in the portal vein were reported to the agency, Intercept said Wednesday.
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