The decision was made based on the drug’s link to an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
There is currently no treatment for PML, a progressive neurological disease. Patients with a compromised immune system are at risk of suffering from an irreversible brain function and in some cases possibly death.
The FDA issued a Public Health Advisory in February warning patients of the associated risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of which died.
Approximately 2,000 patients in the U.S. are currently taking Raptiva for chronic plaque psoriasis. Approved by the FDA in 2003, about 46,000 patients worldwide have been treated with Raptiva.
More information about the withdrawal of Raptiva is available on the Genentech Web site. #