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: "Biogen Idec and Elan said their multiple-sclerosis drug Tysabri has been recommended for approval in Europe.
As the companies await the drug's return to the U.S. market this year, they announced Friday that Europe's Committee for Medicinal Products for Human Use has issued an opinion that Tysabri should be approved for relapsing-remitting MS to delay the progression of disability and reduce the frequency of relapses.
The Committee stipulated that Tysabri be used as single therapy either in patients with highly active relapsing-remitting MS who have failed to respond to treatment with a beta-interferon or in patients who have rapidly evolving severe relapsing-remitting MS.
The European body relied on data from the companies' phase 3 AFFIRM monotherapy trial and the phase 3 SENTINEL trial in which TYSABRI was administered in combination with Avonex (interferon beta-1a).
The Europeans also considered a comprehensive safety analysis the drug makers conducted following reports of three cases of a deadly brain infection -- progressive multifocal leukoencephalopathy -- in patients taking Tysabri. The safety analysis turned up no further cases of PML."
