Biogen Idec, Elan: European committee issues positive opinion for Tysabri to treat multiple sclerosis

By E. Janene Geiss

Philadelphia, April 28 - Biogen Idec and Elan Corp. plc said Thursday that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, issued a positive opinion recommending marketing authorization for Tysabri (natalizumab) as a treatment for relapsing-remitting multiple sclerosis to delay the progression of disability and reduce the frequency of relapses.

The committee recommended that Tysabri be used as single-disease modifying 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, according to a company news release.

In making its recommendation, the committee reviewed available data from the development of Tysabri, including data from the phase 3 Affirm monotherapy trial, the phase 3 Sentinel trial in which Tysabri was added to Avonex (Interferon beta-1a); and a comprehensive safety analysis, which included the assessments for cases of progressive multifocal leukoencephalopathy. The committee also reviewed a risk management plan to assess and minimize risks, including progressive multifocal leukoencephalopathy and other serious opportunistic infections, officials said.

The committee's positive recommendation for Tysabri will be considered for final marketing approval by the European Commission.

Final approval customarily follows the committee's recommendation, which the companies said they anticipate will be this summer. The European Commission is the final decision-making body for all centrally reviewed medicinal products that are to be introduced in the E.U. market.

Biogen Idec is a Cambridge, Mass., biopharmaceutical company focused on oncology, neurology and immunology.

Elan is a Dublin, Ireland, neuroscience-based biotechnology company.

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