PML News

Tysabri Closer to Approval in Europe

At a glance:

The controversial Multiple Sclerosis drug Tysabri is a step closer to approval in the European Union. 
 
An advisory committee has recommended its use in certain cases of MS, as a stand-alone therapy (that is, not in combination with other drugs). 
 
No further cases of the deadly brain condition PML have been detected in Tysabri users. This complication is what led to Tysabri being withdrawn from the market last year. 
 
A decision in the US is expected this summer.


MS drug Tysabri closer to EU launch

United Press International - 4/28/2006 3:03 PM

CAMBRIDGE, Mass., April 28 (UPI) -- 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.

 
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