Genentech Removing Raptiva From U.S. Market

Drug manufacturer Genentech has announced that it is voluntarily withdrawing its psoriasis drug efalizumab, which is marketed as Raptiva, because of life-threatening infections associated with use of the medication.

The company said that physicians should not initiate efalizumab treatment for any new patients and should immediately begin discussions with their patients who currently use the drug about switching to alternative therapies.

Four other biologic agents have been approved for treatment of psoriasis:

Other approved treatments include ultraviolet light therapy and various topical agents. The systemic drugs cyclosporine, which is sold as Neoral; acitretin, which is sold as Soriatane; and methotrexate, which is sold as Rheumatrex and Trexall, also are approved treatments.

The FDA announced last October that it was requiring Genentech to make labeling changes, including the addition of a boxed warning, to highlight the risks associated with use of efalizumab.

In February, the agency issued a public health advisory after three patients who used efalizumab died. The FDA said that there had been three confirmed reports and one possible case of progressive multifocal leukoencephalopathy, or PML, in adults using the drug since it was approved in 2003. All four patients, who ranged in age from 47 to 73 years, had been treated with efalizumab for more than three years; none of them had received other treatments that suppress the immune system while taking the drug.

Three of the patients -- two with confirmed PML and one with possible PML -- died.

In an April 8 news release announcing the withdrawal, the FDA said that efalizumab will not be available in the United States after June 8.

Genentech said it is phasing out the drug during the two-month window to give patients time to transition to another medication. Severe psoriasis can potentially worsen with abrupt discontinuation of efalizumab, according to the company.

The FDA said doctors should continue to monitor patients using the drug for neurologic symptoms that might represent PML, including unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes.

Physicians and patients may report adverse events to the FDA's MedWatch program at (800) FDA-1088 or online. Doctors with questions about Raptiva may contact Genentech at (800) 821-8590.

Genentech estimates that about 2,000 patients in the United States currently are using efalizumab for chronic plaque psoriasis. The manufacturer said its U.S. sales of Raptiva in 2008 were about $108 million.