January 20, 2011
Genentech Inc. began pulling its psoriasis treatment Raptiva from the U.S. market because of the drug’s link to a rare, fatal brain disorder that has troubled at least four other medicines.
Genentech, the biotechnology company acquired last month by Swiss drugmaker Roche Holding AG, has told doctors not to write prescriptions for new patients as part of a phased withdrawal of Raptiva to be completed by June 8, the South San Francisco-based company said yesterday in a statement. About 2,000 U.S. patients may be taking Raptiva, Genentech said
The decision to withdraw the drug, which generated $108 million in U.S. sales for Genentech last year, came after three patients were diagnosed since October with the brain infection progressive multifocal leukoencephalopathy, two of whom died, said Tara Cooper, a Genentech spokeswoman. The risk of PML, which causes irreversible brain damage, outweighed Raptiva’s benefits in controlling psoriasis, the company concluded.
“We said, and the Food and Drug Administration agreed, that Raptiva likely causes PML,” said Ivor Caro, Genentech’s senior medical director for dermatology, in a telephone interview. What tipped the balance was that Genentech could neither predict which patients were likely to develop PML, nor come up with a strategy to lessen that risk, he said.
“It was the clinical science perspective, not how much Raptiva was being sold,” Caro said.
$125 Million Charge
The withdrawal will result in a one-time charge of about $125 million, the company said.
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