Suddenly, PML is cropping up all over the place. Genentech announced another case of progressive multifocal leukoencaphalopathy, the potentially deadly brain infection, in a 73-year-old women who used its Raptiva psoriasis treatment. It's the second PML case reported among Raptiva users, both in patients in their 70s. Both patients died.
According to a Dear Doctor letter issued by the company, Genentech believes that Raptiva "likely increases the risk of PML." In addition, both patients used the drug for several years, raising the possibility that prolonged Raptiva exposure, combined with older age, may further increase that PML risk.
Genentech says it's working with the FDA on any "appropriate next steps." As you know, Raptiva's label was updated last month with a "black box" warning of serious infections, including PML. Meanwhile, Merck KGaA, which markets Raptiva in Europe, said it's working with European regulators on a label update and that it's also "seeking to determine if further action is needed."
So far this year, PML has been reported not only in these two Raptiva patients, but in several patients taking the Biogen Idec multiple sclerosis treatment Tysabri; in patients on the Novartis immunosuppressant drugs--used in transplant patients but also off-label for some lupus sufferers--CellCept and Myfortic; and in one patient using Genentech's arthritis treatment Rituxan.