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Second case of PML seen with psoriasis drug Raptiva
Wednesday 19 November 2008
Malini Guha - Science Editor
Genentech has issued a "Dear Healthcare Provider Letter" regarding a second case of progressive multifocal leucoencephalopathy (PML) in a patient taking its psoriasis treatment Raptiva (efalizumab) which resulted in death, and said it was working with the US FDA to determine its next steps.
In October, a "black box" warning was added to Raptiva's label about the risk of life-threatening infections, including progressive multifocal leucoencephalopathy (Scrip Online October 17th, 2008). The FDA also required 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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