PML boxed warning and REMS for Genentech's Raptiva
This article was originally published in Scrip
Executive Summary
The US label for Genentech's psoriasis therapy Raptiva (efalizumab) has added a "black box" warning about the risk of life-threatening infections, including progressive multifocal leucoencephalopathy (PML). The FDAalso is requiring Genentech to develop a medication guide as part of a new risk evaluation and mitigation strategy (REMS) for the humanised monoclonal antibody.