Genentech Takes Raptiva off the Market
April 9, 2009
On April 8, 2009, the Genentech, manufacturer of the psoriasis drug, Raptiva, announced that it is pulling Raptiva from the U.S. market because the drug poses an increased risk of progressive multifocal leukoencephalopathy (“PML”), a rare and serious fatal disease of the central nervous system. PML is a progressive neurologic disease caused by a virus. It typically occurs in people with weakened immune systems because the virus can attack the myelin, or white matter, that surrounds and protects brain cells. There is no known treatment. PML is the same disease that has been linked to the multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan Corp.
Regulators Warned of Dangers Risks Associated with Raptiva
Although the Food and Drug Administration (“FDA”) originally approved Raptiva in 2003, in October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of potentially fatal infections, including PML. In February 2009, the FDA again issued a warning regarding the dangers posed by Raptiva. Additionally, Europe’s main medical regulator recommended a Raptiva withdrawal from the European market.
To date, there have been three cases of patients diagnosed with PML after being treated with Raptiva, and one patient who developed progressive neurologic symptoms and later died of unknown causes.
Raptiva Sales in the United States
Raptiva, which has been used to treat chronic moderate to severe plaque psoriasis, registered sales of $242 million last year, including $108 million by Genentech. Genentech estimates that approximately 2,000 patients in the United States are currently being treated with Raptiva, and since the FDA’s 2003 approval of Raptiva, it has been prescribed to approximately 46,000 patients.
Further Actions to be Taken
Genentech is advising prescribers that they should not issue prescriptions for Raptiva for new patients and should contact those taking Raptiva to assess alternative treatments. The company also said that Raptiva will no longer be available as of June 8, 2009.