Genentech pulls Raptiva over PML riskGenentech and FDA announced the withdrawal of psoriasis treatment Raptiva due to a risk of progressive multifocal leukoencephalopathy (PML), a rare and deadly viral brain infection.
The agency added a black-box warning to the biologic's labeling in October, cautioning of the risk of PML as well as bacterial sepsis, viral meningitis and invasive fungal disease for patients on the drug. The Roche-owned company issued a “Dear Patient” letter in March announcing a new Raptiva medication guide and warning of the PML risk. The drug will no longer be available after June 8.
Indicated for chronic moderate to severe plaque psoriasis in those 18 and over, Raptiva helps tamp down flare-ups by suppressing the immune system. That, however, can open the door to the JC virus thought to be behind PML, which destroys the white matter in the brain. PML was often seen in AIDS patients before the advent of antiretroviral drugs.
The treatment won FDA approval in late 2003. Since then, it has been used to treat around 46,000 patients worldwide. There have been three diagnosed cases of PML in Raptiva patients and one case of a patient treated with Raptiva who developed progressive neurologic symptoms and died of unknown causes. The company estimates that around 2,000 in the US are currently using the treatment.
US sales of Raptiva in 2008 brought in $108 million.