Genentech withdrew its psoriasis drug Raptiva from the market yesterday, citing the risk of developing progressive multifocal leukoencephalopathy (PML), a rare, often fatal brain infection. The drug will be phased out by June 8 of this year, according to a statement by the US Food and Drug Administration (FDA).
The decision comes after Genentech reported a fourth case of PML diagnosed in a 47 year old man in Germany in February, and a subsequent warning by the FDA. Three other people taking Raptiva have developed PML, two of whom died.
Raptiva is an antibody therapy that reduces psoriasis flare-ups by suppressing T-cells. Sales of the drug were $108 million in 2008, and about 2,000 people are currently taking it, according to a statement by Genentech.
The withdrawal won't hurt Genentech's bottom line much, said Simos Simeonidis, a senior biotechnology analyst and director at Rodman & Renshaw, LLC. "It was not ever a major source of revenue for Genentech, especially in the psoriasis indication...I think actually the effect right now will be null," he said
Last month, the FDA unanimously recommended approval for the use of Genentech's anti-cancer drug Avastin for glioblastoma multiforme, a deadly form of brain cancer. The expanded market for Avastin will likely outweigh the loss of revenue from Raptiva, he said, adding that Genentech's recently completed merger with the pharma giant Roche won't be affected.
PML primarily affects people with weakened immune systems, spurring a normally harmless virus, called Polyomavirus JC, to destroy the myelin sheaths surrounding nerves in the brain. There is no known treatment for the infection. Seven patients have also developed PML while taking Biogen Idec's multiple sclerosis drug Tysabri.
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