Elan and partner Biogen Idec were left celebrating yesterday after the National Institute for Health and Clinical Excellence issued guidance recommending Tysabri (natalizumab) for the treatment of multiple sclerosis.
The Institute released its final appraisal document recommending the drug last month, opening up a period of consultation for any objections to its guidance, but has now given full consent for doctors to prescribe the treatment on the National Health Service.
“Having considered the evidence presented on the use of natalizumab for the treatment of multiple sclerosis within its licensed indications, along with responses received during the consultation, the independent advisory committee decided that natalizumab should be an option for the treatment only of rapidly evolving severe relapsing–remitting multiple sclerosis. This guidance is good news for people with this particular severe form of multiple sclerosis,” commented Andrew Dillon, executive lead for the appraisal.
The victory is especially sweet for Elan and Biogen given the rocky road Tysabri has travelled to market. Shortly after being launched in the USA, the drug was quickly pulled back off the shelves in February 2005 after being linked to a rare brain infection and a small number of fatalities. But following a safety review by US regulators, the monoclonal antibody was licensed across Europe in June last year, and placed on NICE’s fast-track programme for approvals in August.
Success in clinical trials
European 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.
And fresh data from a clinical study unveiled earlier this week showed that MS patients treated with Tysabri showed a significant improvement in health-related quality-of-life measures when compared to placebo, findings which have “not have not been previously observed in clinical studies involving MS patients,” according to Richard Rudick, lead investigator of the study.