Genentech Pulls Psoriasis Drug Raptiva Due To Risk of Fatal Brain Infection

Today, Genentech and the U.S. Food & Drug Administration (FDA) announced a voluntary withdrawal of the drug Raptiva (efalizumab).  According to the statement issued by the FDA, “The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.”

Prescribers are being asked not to initiate Raptiva treatment for any new patients.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches of skin. On Oct. 16, 2008, the FDA updated the labeling for Raptiva to warn of the risk of life-threatening infections, including PML. Then, on Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva’s labeling regarding PML.