ROCKVILLE, Md., Oct. 16 2008
-- The FDA today announced that efalizumab (Raptiva) must carry a boxed warning to highlight the risk of life-threatening infections, including progressive multifocal leukoencephalopathy (PML).
The warning will also include an increased risk of bacterial sepsis, viral meningitis, and invasive fungal disease.
The demand for updated labeling comes after reports to the FDA's Office of Surveillance and Epidemiology of hospitalizations and deaths resulting from infections associated with the use of the drug.
Because efalizumab works by suppressing the immune system to reduce psoriasis flare-ups, it can also increase the risk of serious infection, the FDA said. Last week, drug maker Genentech reported that a 70-year-old patient who had been taking efalizumab for four years died from PML.
Other label changes called for in the FDA action include the addition of data from juvenile animal studies in mice that found a potential risk for the permanent suppression of the immune system with repeat administration of the drug. Efalizumab is not approved for children under 18.
Efalizumab is a once-weekly injection to treat moderate to severe plaque psoriasis in patients who are candidates for whole-body therapy or phototherapy. http://www.medpagetoday.com/InfectiousDisease/PublicHealth/11358
Genentech Announces Voluntary Withdrawal of Raptiva from the U.S. Market
On April 8, 2009, Genentech announced a phased voluntary withdrawal of the psoriasis drug RaptivaŽ (efalizumab) from the U.S. market. The company's decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.
Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives. Raptiva will no longer be available after June 8, 2009. This transition period is intended to allow patients, who are currently taking Raptiva, enough time to work with their doctors to appropriately discontinue use of Raptiva
. Because of the potential for severe psoriasis worsening with abrupt discontinuation of Raptiva, it is important that patients talk with their doctor before stopping treatment.
The Raptiva prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML, in patients receiving Raptiva. The Raptiva prescribing information was further updated in March 2009 to include additional information on the risk of PML and a new Medication Guide for patients. http://www.gene.com/gene/products/information/immunological/raptiva/