Incivek regulatory update

FDA added a warning to the label for HCV drug Incivek telaprevir from Vertex about the potential for serious or life-threatening adverse reactions such as cardiac arrhythmias when used in combination with antipsychotic pimozide, an already contraindicated drug. FDA also added information on monitoring, drug interactions and clinical trial data. The updated label includes guidelines on monitoring for hemoglobin and HCV-RNA levels, and removes desipramine, an antidepressant, as a drug contraindicated with Incivek. The updated label also includes data from 3 Phase III trials - Study C216, ADVANCE and ILLUMINATE. ...