The National Institute for Health and Clinical Excellence has issued a final appraisal document recommending the use of Elan and Biogen Idec’s Tysabri to treat National Health Service patients with multiple sclerosis.

According to the MS Society, NICE had been poised to reject Tysabri (natalizumab) on grounds of cost and efficacy, but changed its mind to recommend the drug for highly active relapsing MS - defined as having had two or more disabling relapses in the last year - following a strong consultation response.

“For the small number of people with this highly active form of MS – we understand around 3,000 people UK-wide could stand to benefit – Tysabri represents a vital treatment option. We welcome NICE's decision to take note of the consultation response,” said Simon Gillespie, chief executive of the MS Society.

Rocky start

After a rocky start, which saw Tysabri temporarily withdrawn from the US market after being linked to a rare brain infection and a small number of fatalities, the monoclonal antibody was licensed across Europe in June last year and placed on NICE’s fast-track programme in August.

Approval was based on two-year data from clinical trials involving nearly 1,000 patients that showed a 42% reduction in the risk of progression to disability, and a 68% relative reduction in the rate of clinical relapses over the study period.

A spokeswoman for NICE told PharmaTimes UK News that the deadline for responses to its FAD is July 16, and that final guidance could be issued as early as next month, if there are no appeals.

If the full green light is given, Tysabri will be the “first treatment to be recommended for use by NICE, a significant milestone for patients suffering from MS,” said Dr Menghis Bairu, Head of Elan International.