There will be a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.
Raptiva has recently been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
Authorities in Europe, where Raptiva is sold by Merck KGaA (MRCG.DE), recommended in February that the drug be suspended in light of the PML risk.
The European Commission is expected to follow that advice.
There have been three cases of diagnosed PML in patients receiving Raptiva, two of which were fatal, and a fourth patient who developed progressive neurologic symptoms and died of unknown causes.
Raptiva is approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or light therapy.
PML has also become an issue for patients treated with multiple sclerosis drug Tysabri, which is sold by Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I).