Biogen and Elan get MS drug approval from EU

Biogen and Irish pharmaceuticals company Elan have revealed that the European Medicine Agency’s committee for medical products for human use (CHMP) has approved the marketing of multiple-sclerosis (MS) drug Tysabri. It was developed for use on MS patients who do not respond to treatment with beta-interferons or in patients have rapid and severe relapsing-remitting MS.

The committee studied data from phase III trials and a comprehensive safety analysis which examined the risk of progressive multifocal leukoencephalopathy (PML) developing through use of the drug. Earlier trials submitted to the FDA suggested that the Tysabri prevented MS relapses by 66 per cent, but last year shares in Elan and Biogen plummetted after Tysabri was withdrawn due to the death of one user who developed PML, a rare central nervous system infection.

Tysabri, which is also used for rheumatoid arthritis and Crohn’s disease, will now be referred to the European Commission for final marketing approval, which normally follows the CHMP’s recommendations as a matter of custom, according to both companies.

Shares in Elan increased by 18 per cent on release of the news, after the company cited “unexpected challenges” earlier in the year as it revealed a loss for its 2005 full-year results.

Biogen and Elan say they expect a decision from the FDA on Tysbabri by the end of June.

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