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Genentech to remove Raptiva from market

Mar 4, 2010 | Staff | BNet News

Raptiva, the psoriasis drug from Genentech Inc. that has been linked to a rare but serious neurologic disease, is expected to be unavailable in the United States after June 8.

The biotechnology company has announced a voluntary recall, saying there is a potential risk that patients may develop progressive multifocal leukoencephalopathy (PML), a rare disease caused by a virus that attacks the central nervous system.

The Food and Drug Administration has advised prescribers not to initiate Raptiva (efalizumab) treatment for new patients and to engage in discussions with those already on the therapy of avenues for transitioning to alternative treatments. The FDA approved Raptiva, a once-weekly injection for adults with moderate to severe plaque psoriasis, in 2003.

"Our decision to remove Raptiva from the market reflects our commitment to patient safety," says Hal Barron, senior vice president of development and chief medical officer at Genentech. "Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."

Raptiva's prescribing information was updated last October to include a boxed warning on the risks of PML and other serious infections in patients receiving the injection. The FDA issued a public health advisory in February to inform patients and prescribers of the risk of PML in patients taking Raptiva. And in March the labeling was updated again to include more information on the PML risk and alert patients about the availability of relevant medication guides.

U.S. sales of Raptiva were approximately $108 million in 2008. Genentech estimates that about 2,000 patients in this country may be receiving Raptiva for chronic plaque psoriasis. Since Raptiva's approval by the FDA in 2003, roughly 46,000 patients worldwide have been treated with Raptiva.