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FDA: MS Drug Tysabri Can Return to Market

Posted on: Monday, 5 June 2006, 15:00 CDT

The Food and Drug Administration said Monday that Biogen Idec/Elan's multiple-sclerosis drug Tysabri can return to market.

The agency said the treatment can be sold once again -- following the drug's suspension last year from the marketplace -- to treat relapsing forms of MS.

The reintroduction of the drug, however, comes with the stipulation that Tysabri should only be used as a single therapy and not in combination with other MS treatments.

Biogen Idec and Elan said they expect the drug will be available in July following completion of a risk-management plan that they said would include FDA review of educational and training materials, internal validation of systems based on final FDA requirements, and personnel training.

Today represents a significant step forward for people with relapsing MS. The reintroduction of TYSABRI offers new hope as an important therapeutic choice for patients living with this disabling disease, said James Mullen, chief executive officer of Biogen Idec.

The companies pulled the drug from the market last year following three reports of a rare but deadly brain infection in patients using the treatment.

An advisory panel to the FDA recommended March 8 that the drug return to market to control MS flare-ups. The panel's decision was based on an analysis in MS patients on Tysabri therapy, which showed no further cases of the lethal side effect.

Source: United Press International

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