Genentech pulls drug from market for safety

Genentech Inc. is pulling the psoriasis treatment Raptiva off the U.S. market because of links to an often fatal brain infection.

The move comes about six months after the company updated the drug’s labeling to carry warnings of links to a rare nervous system disorder called progressive multifocal leukoencephalopathy, or PML. Genentech, a unit of Swiss drug maker Roche Holding, said it made the decision to pull the drug in conjunction with the U.S. Food and Drug Administration.

Three cases of PML in patients taking Raptiva have been confirmed. One other patient on the drug developed similar neurological symptoms and died of an unknown cause, the company said.

The FDA confirmed those cases in February, the same day that regulators in the European Union recommended banning the drug.

Genentech estimates that about 2,000 people in the United States are now taking the drug and about 46,000 worldwide have taken it since its introduction in 2003. Raptiva accounted for $108 million in sales in 2008 out of the company’s total of $13.42 billion.

The drug was approved for patients with chronic moderate to severe plaque psoriasis, a condition characterized by red, scaly, inflamed patches of skin.

PML is typically seen in patients with weakened immune systems, and previously has been reported in patients taking Rituxan, a blockbuster arthritis and cancer drug marketed by Genentech and Biogen Idec Inc., and Tysabri, a multiple sclerosis treatment marketed by Biogen Idec and Elan Corp.

Genentech said that no new prescriptions should be written and that the drug would no longer be available after June 8. But the company said patients should talk with their doctors before stopping use.