Raptiva Recalled in U.S. Due To Link With Fatal Brain Infection, Progressive Multifocal Leukoencephalopathy (PML)
(Posted by Tom Lamb at DrugInjuryWatch.com)
On April 8, 2009 Genentech Inc. -- which was just acquired by Roche Holding AG in March 2009 -- issued a press release announcing "a phased voluntary withdrawal of psoriasis drug Raptiva® (efalizumab) from the U.S. market" due to its link to a brain infection, progressive multifocal leukoencephalopathy (PML).
Here is a basic timeline for Raptiva, from product launch to drug recall.
2003: Raptiva was approved by the FDA as a once-weekly injection for adults with moderate to severe plaque psoriasis.
October 2008: FDA announced updated labeling for Raptiva to warn of the risk of life-threatening infections, including progressive multifocal leukoencephalopathy (PML).
December 2008: U.S. sales of Raptiva were approximately $108 million in its last full year on market.
February 2009: FDA issued a Public Health Advisory for Raptiva informing patients and doctors about the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died.
February 2009: The same day (February 19) that the FDA issued its Public Health Advisory, the European Medicines Agency announced the benefits of Raptiva do not outweigh its risks. Accordingly, this regulatory body recommended that the use of Raptiva should be suspended in the European Union.
February 2009: Two days later (February 21), at the recommendation of Health Canada, the marketing of Raptiva in Canada was suspended due to safety concerns, including the increased risk of developing PML.
March 2009: FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.
April 2009: Genentech announces "phased voluntary withdrawal" of Raptiva and sends out a Dear Healthcare Professional Letter, or "Dear Doctor" letter, about Raptiva as well as a Dear Patient Letter about Raptiva.
June 2009: Raptiva will no longer be available to patients in the U.S.
To put this Raptiva recall into context, here is some information about progressive multifocal leukoencephalopathy (PML) from the April 8, 2009 Genentech press release about Raptiva:
PML is a rare, progressive, demyelinating disease of the central nervous system that leads to death or severe disability. PML is caused by activation of the John Cunningham, (JC) virus. The JC virus resides in latent form in up to 80 percent of healthy adults, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood, though abnormalities in T-cells may be important for reactivation and PML. PML has been reported in the published literature in HIV-positive patients, as well as immunosuppressed cancer patients (including patients with hematologic malignancies), organ transplant recipients, and patients with autoimmune diseases. There are no known interventions that can reliably prevent or adequately treat PML.
Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva, with approximately 2,000 patients in the U.S. currently receiving Raptiva at time this drug recall was announced in early April 2009 by Genentech.