Mass Torts Update - Written by Jere Beasley on Monday, May 4, 2009 14:09 - 0 Comments
Genentech withdraws psoriasis drug linked to brain infections
Genentech Inc. has started to pull 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 in March by Swiss drug maker Roche Holding AG, has told doctors not to write prescriptions for new patients as part of a phased withdrawal of Raptiva, which is to be completed by June 8th. According to Genentech, about 2,000 U.S. patients may currently be taking Raptiva.
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 (PMT), two of whom died. The company has concluded that the risk of PML, which causes irreversible brain damage, outweighed Raptiva’s benefits in controlling psoriasis. Raptiva, approved in 2003, was designed to suppress the abnormal immune response that triggers psoriasis, a painful, scaly rash that afflicts about 7.5 million Americans, according to the National Psoriasis Foundation.
At least four other drugs have been linked to PML risk. They include Roche’s Cellcept, used to prevent transplant rejections; Biogen Idec Inc. and Genentech’s cancer drug Rituxan; Biogen’s multiple sclerosis treatment Tysabri and Genzyme’s leukemia drug Campath. PML occurs when a common germ, called JC virus, mutates, then evades the body’s immune defenses and penetrates the brain. Folks with suppressed immune systems are most at risk for PML.
Source: Bloomberg
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