EMEA proposes measures to better manage Tysabri's PML risks; positive opinions from CHMP include two on GSK products
The European Medicines Agency (EMEA) has finalized a review of Tysabri (natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by the JC virus, saying the drug continues to outweigh risks for patients with highly active relapsing-remitting multiple sclerosis who have few options for alternative treatment.
Tysabri, developed by the USA's Biogen Idec and marketed in Europe with partner Elan, was withdrawn from sale in February 2005 and introduced in July 2006 following side effect problems, but just this month the US firm said that it had generated revenues of over $1 billion for 2009 (The Pharma Letter January 13).
The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the risk of developing PML increases after two years of Tysabri use, although this risk remains low.
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