PML boxed warning and REMS for Genentech's Raptiva
This article was originally published in Scrip
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.
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