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Genentech withdraws Raptiva

Psoriasis treatment is withdrawn from US market because of increased risk of PML

Genentech has announced the phased voluntary withdrawal of its psoriasis drug Raptiva from the US market because of an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Raptiva, which is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years and older, will no longer be available after June 8, 2009. However, effective immediately, doctors have been advised not to prescribe the drug to new patients. In addition, doctors have been asked to contact patients currently receiving the drug to discuss alternative treatment options.

"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," said Dr Hal Barron, Genentech senior vice president, development and chief medical officer. "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," he added.

There have been three cases of diagnosed PML in patients receiving Raptiva: one patient receiving the drug developed progressive neurologic symptoms and died of an unknown cause.

Genentech's decision to withdraw the drug was taken after consultation with the Food and Drug Administration (FDA). The company is working with Merck Serono, its licensee outside the US and Japan, to inform regulators of the decision to remove the treatment from the US market.

Raptiva prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML. It was further updated last month to include additional information on the risk of PML and a new medication guide for patients.

Approximately 2,000 patients in the US are currently taking Raptiva for chronic plaque psoriasis, according to Genentech and 46,000 people worldwide have received the treatment since it was approved by the FDA in 2003.

9th April 2009

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