LOS ANGELES, April 8 (Reuters) - Genentech Inc, which was acquired by Roche Holding AG last month, announced on Wednesday a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.
Raptiva has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
The drug, licensed from Xoma Ltd, had 2008 U.S. sales of $108 million.
Roche said it expects to record a $125 million charge for the withdrawal, but its 2009 targets would not be affected.
Authorities in Europe, where Raptiva is sold by Merck KGaA , 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 and one patient treated with Raptiva 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.
Genentech said that, effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving the drug to assess the most appropriate treatment alternatives.
The company said Raptiva will not be available after June 8 and estimated that around 2,000 U.S. patients may be receiving the drug for chronic plaque psoriasis.
(Reporting by Deena Beasley; editing by Carol Bishopric and Matthew Lewis) Keywords: GENENTECH ROCHE/RAPTIVA (deena.beasley@thomsonreuters.com; + 1 213-955-6746; Reuters Messaging: deena.beasley.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
Raptiva has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
The drug, licensed from Xoma Ltd, had 2008 U.S. sales of $108 million.
Roche said it expects to record a $125 million charge for the withdrawal, but its 2009 targets would not be affected.
Authorities in Europe, where Raptiva is sold by Merck KGaA , 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 and one patient treated with Raptiva 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.
Genentech said that, effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving the drug to assess the most appropriate treatment alternatives.
The company said Raptiva will not be available after June 8 and estimated that around 2,000 U.S. patients may be receiving the drug for chronic plaque psoriasis.
(Reporting by Deena Beasley; editing by Carol Bishopric and Matthew Lewis) Keywords: GENENTECH ROCHE/RAPTIVA (deena.beasley@thomsonreuters.com; + 1 213-955-6746; Reuters Messaging: deena.beasley.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.