Genentech pulls psoriasis drug from US market
SOUTH SAN FRANCISCO, Calif. - The Genentech unit of drug maker Roche Holding AG is pulling the psoriasis treatment Raptiva from the US market because of links to an often fatal brain infection.
The move comes only about six months after the company updated the drug's labeling to carry warnings of links to progressive multifocal leukoencephalopathy, or PML, a rare nervous system disorder. Genentech said it made the decision to pull the drug in conjunction with the Food and Drug Administration.
Three cases of PML in Raptiva patients have been confirmed. One other patient on the drug developed similar neurological symptoms and died of an unknown cause, the company said.
Tysabri, a treatment for multiple sclerosis made by Biogen Idec of Cambridge, has also been linked to PML. Tysabri was pulled from the market in February 2005, and the company was allowed to resume selling the drug in July 2006. Since then, four new cases of PML have been reported in Tysabri users.
Genentech estimates about 2,000 people in the United States are taking Raptiva and about 46,000 worldwide have taken it since its introduction in 2003. Raptiva accounted for $108 million in sales in 2008 out of Genentech's total of $13.42 billion.
The drug was approved for chronic moderate to severe plaque psoriasis, a skin condition characterized by red, scaly, inflamed patches of skin.
The company said no new prescriptions should be written, and the drug will no longer be available at all after June 8. Genentech says patients should consult their doctors before stopping use of the drug, because an abruptly halt can lead to sudden worsening of the psoriasis.
"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," Hal Barron, a Genetech senior vice president, and chief medical officer, said in a statement. "Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk . . . has significantly changed."
Switzerland-based Roche Holding last month acquired the share of Genentech it didn't already own in a $47 billion deal.
Roche said its earnings won't be significantly affected by the decision, but it would take a $125 million charge for supplies of the medicine made but not sold.
Merck Serono, which has the license to distribute the drug outside the United States and Japan, will alert other countries to the decision to pull the drug in the United States, Genentech said.