Tysabri gets EC approval for relapsing MS

USA-based pharmaceutical firm Biogen Idec and Ireland's Elan say that the European Commission has granted marketing approval for the co-developed multiple sclerosis drug Tysabri (natalizumab). The drug is indicated for the treatment of relapsing remitting forms of the condition, and is designed to delay disease progression.

The decision follows the positive opinion that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use issued regarding the drug earlier in the year (Marketletter May 8).

In February of last year, Tysabri was withdrawn from the US market, after the death of two subjects participating in clinical trials from the rare brain disease progressive multifocal leukoencephalopathy. The US Food and Drug Administration has since reapproved the product for MS, albeit with additional usage restrictions, having established that no further cases of PML were linked to its use.