Genentech's Raptiva gets Boxed Warning on risk of infections including PML
The US Food and Drug Administration has ordered Genentech to place a Boxed Warning on its psoriasis drug Raptiva (efalizumab), highlighting the risks of life-threatening infections, including progressive multifocal leukoencephalopathy.
The labeling changes are based on the agency's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy, which will include a Medication Guide for patients and a timetable for assessment of the REMS.
The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.
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