Sober news from Genentech today: A fatal case of progressive multifocal leukoencephalopathy, or PML, has cropped up in an arthritis patient treated with the blockbuster drug Rituxan. The patient was diagnosed 18 months after the last dose of the med in a long-term safety study. It was a complicated case, with several co-morbidities, and in a patient who'd been on immunosuppressive therapy for a long time.
PML, of course, is the brain infection that sidelined the multiple sclerosis med Tysabri back in 2006; the drug came back on the market accompanied by a strict risk management program. PML arose again recently in a handful of Tysabri patients, and the new cases were added to the drug's labeling info. Strangely enough, Tysabri is sold by Biogen Idec, in partnership with Elan. And Biogen Idec is Genentech's partner on Rituxan, which brought in $2.28 billion last year.
The FDA is telling healthcare providers to "maintain an index of suspicion for PML" in Rituxan patients with neurologic symptoms. Genentech noted that the drug's label already mentions a risk of PML, and cited the complicated nature of this fatal case, saying that the role Rituxan played in the person's death is unknown.
Two patients being treated for lupus also had fatal cases of PML back in 2006.