Biotech Genentech Inc has notified doctors that a 70-year-old patient being treated for chronic psoriasis with its drug Raptiva (efalizumab) for more than four years had developed the mostly fatal brain disease called progressive multifocal leukoencephalopathy (PML).
Genentech said it will work with the U.S. Food and Drug Administration to update the prescribing information for Raptiva and determine if further action is needed.
Raptiva is also marketed by Merck KGaA in Europe, with sales of around $ 72 million dollars in the first half of 2008. In the U.S., Raptiva generated $ 49 million dollars for Genentech in the same period.
Last month, Genentech reported it had revised the label and prescription of its treatment for rheumatoid arthritis and non-Hodkin´s lymphomas Rituxan (generically rituximab) to note the death from PML of a rheumatoid arthritis patient treated with the drug. The brain infection had already been noted on Rituxan´s label as a possible risk.
The brain disease began to be more globally known after Biogen Idec and Ireland´s Elan Corp removed their multiple scelerosis drug Tysabri from the market in February 2005 due to its link with PML. Tysabri was brought back onto the market some 18 months later, and this year some PML cases have still been reported in multiple sclerosis patients on this drug.
Rituxan, which generated earnings for over $ 1.25 billion dollars in the first half of 2008, was jointly developed by Biogen Idec and Genentech.
Genentech said there are no other cases of confirmed PML in patients treated with Raptiva, although there has been a report of a 62-year old patient treated with Raptiva who developed progressive neurologic symptoms and died of an unknown cause.
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Genentech said it will work with the U.S. Food and Drug Administration to update the prescribing information for Raptiva and determine if further action is needed.
Raptiva is also marketed by Merck KGaA in Europe, with sales of around $ 72 million dollars in the first half of 2008. In the U.S., Raptiva generated $ 49 million dollars for Genentech in the same period.
Last month, Genentech reported it had revised the label and prescription of its treatment for rheumatoid arthritis and non-Hodkin´s lymphomas Rituxan (generically rituximab) to note the death from PML of a rheumatoid arthritis patient treated with the drug. The brain infection had already been noted on Rituxan´s label as a possible risk.
The brain disease began to be more globally known after Biogen Idec and Ireland´s Elan Corp removed their multiple scelerosis drug Tysabri from the market in February 2005 due to its link with PML. Tysabri was brought back onto the market some 18 months later, and this year some PML cases have still been reported in multiple sclerosis patients on this drug.
Rituxan, which generated earnings for over $ 1.25 billion dollars in the first half of 2008, was jointly developed by Biogen Idec and Genentech.
Genentech said there are no other cases of confirmed PML in patients treated with Raptiva, although there has been a report of a 62-year old patient treated with Raptiva who developed progressive neurologic symptoms and died of an unknown cause.
Network Medica
CLICK HERE FOR FULL ARTICLE & RELATED INFORMATION
