Genentech Begins Phased Withdrawal of Raptiva

Genentech, maker of psoriasis drug Raptiva, announced a voluntary, phased withdrawal of the product. Raptiva poses a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a progressive neurologic disease that affects the nervous system.

PML is a rare and serious condition generally associated with long-term use of Raptiva. Patients with weakened immune systems are more susceptible to PML, which often leads to permanent decline in neurologic function and death.

The FDA approved Raptiva in 2003 as a once-weekly injection for adults with plaque psoriasis. On Oct. 16, 2008, the FDA updated the FDA-approved labeling to warn of the risk of PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory about the risks of Raptiva following reports of four patients diagnosed with PML, three of whom died.

Physicians should not issue prescriptions for Raptiva to any new patients. The phased withdrawal is meant to allow patients time to transition to alternative treatments, since psoriasis may worsen with abrupt discontinuation. Prescribers of Raptiva should be aware of neurologic symptoms of PML and report suspected cases to FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch.

AUTHOR: Annette Hulbert