Raptiva suspended in Europe over safety concerns
pharmafile | February 20, 2009 | News story | Research and Development, Sales and Marketing | Europe, Rapitva
Psoriasis treatment Raptiva is to be suspended from use in the European Union because of concerns about rare but serious side effects.
Only three confirmed cases of the side-effect progressive multifocal leukoencephalopathy (PML) have been confirmed in patients taking the drug, but all of these patients have died from the serious brain infection.
The EMEAs Committee for Medicinal Products for Human Use conducted a benefit/risk review of the drug, and concluded Raptiva's benefits no longer outweigh its risks.
European marketer Merck Serono is to respond immediately to the regulator's request and suspend Raptiva from the market.
PML is caused by the reactivation of a common virus in the central nervous system, and is only seen in immune-compromised individuals.
The first two cases were reported in the US, where the drug is marketed by Genentech, which developed the drug.
Those cases occurred in patients aged 70 or older, who received Raptiva for approximately four years.
A third virologically confirmed PML case was recently reported in a patient aged 47 from Germany, who had been treated with Raptiva for more than three years. A fourth case suggestive of PML was previously reported, but not virologically confirmed.
It seems unlikely that Raptiva (efalizumab) will ever return to the market following this ruling, and Merck Serono has been quick to play down its commercial significance.
Merck Serono says its sales of Raptiva amounted to 93 million euros in 2008 and actually lost money marketing the drug, once its costs were taken into consideration. The company added that it had completely written off any revenues for the 2008 financial year.
The drug is equally not a significant product for US marketers Genentech, earned $108 million from the drug in 2008. US regulators the FDA are expected to make a similar ruling on the drug shortly and recommend its suspension.
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