Sept 25 (Reuters) - Intercept Pharmaceuticals Inc said on Monday an update to the label of its liver drug, Ocaliva, could include a boxed warning to help ensure proper dosing of patients, but added that it did not expect the change to be restrictive.
A boxed warning is the strictest warning by the U.S. Food and Drug Administration (FDA) that appears on a drug’s label, calling attention to serious or life-threatening risks of a drug.
The FDA last week warned about Ocaliva being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death.
Intercept’s shares were up 5.5 percent at $65.00 in early trading on Monday. (Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar)