September 25, 2017 / 11:19 AM / a year ago

BRIEF-Intercept Pharmaceuticals comments on Ocaliva safety and dosing in liver disease patients​

Sept 25 (Reuters) - Intercept Pharmaceuticals Inc

* Intercept Pharmaceuticals Inc comments on Ocaliva (obeticholic acid) safety and dosing in primary biliary cholangitis (PBC) patients​

* Intercept Pharmaceuticals - In course of co’s post-marketing pharmacovigilance activities, deaths have been reported in pbc patients with moderate or severe hepatic impairment​

* Intercept - In analysis performed by co, it concluded that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than recommended weekly dose in such patients

* Intercept Pharmaceuticals - Says ‍in addition to DHCP letter, co has taken certain actions to enhance education about appropriate use of ocaliva​

* Intercept Pharmaceuticals - Says ‍initiatives include reeducating physicians on label, enhancing monitoring of patients for liver-related adverse reactions​

* Intercept Pharmaceuticals - Pursuant to FDA’s safety communication, co has begun working with FDA on updates to label to better ensure appropriate and safe use of Ocaliva​ Source text for Eikon: Further company coverage:

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