April 9, 2009 — Efalizumab (Raptiva, Genentech, Inc) is undergoing a voluntary, phased withdrawal in US markets because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML).
Efalizumab will no longer be available in the United States after June 8, 2009, and healthcare providers are being asked not to initiate treatment in new patients.
"The intent of the phased withdrawal is to provide sufficient time for prescribers to identify their patients on Raptiva, inform them that they need to discontinue treatment, and plan a careful transition to alternative psoriasis therapies as appropriate," the manufacturers state in a letter to healthcare professionals.
According to a US Food and Drug Administration (FDA) statement, the risk that an individual patient taking efalizumab 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," the FDA notes.
Prescribers should immediately begin discussing with patients currently using efalizumab how to transition to alternative therapies. "The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis," states the MedWatch report on the withdrawal. Prescribers should also continue to closely monitor patients for any sign or symptom that is suggestive of PML and for infections or other adverse events after stopping treatment.
The labeling for efalizumab was updated previously on October 16, 2008, to warn of the risk for life-threatening infections, including PML. Subsequently, after receiving reports of 4 patients with PML, 3 of whom died, the FDA issued a public health advisory. On March 13, 2009, the FDA approved a medication guide for efalizumab and added information to the labeling regarding PML.
Efalizumab is used for the treatment of chronic moderate to severe plaque psoriasis.
Efalizumab is an anti-CD11a antibody immunosuppressant drug. PML is a rapidly progressive infection of the central nervous system caused by the John Cunningham (JC) virus that leads to death or severe disability. It is currently not possible to identify patients at increased risk for PML before or during efalizumab therapy, and there is no known treatment for PML.
Adverse events related to use of efalizumab should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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