Call Tysabri the comeback kid. The multiple sclerosis drug, made by Elan and Biogen Idec, was pulled from the U.S. market in 2005 after reports of its links to a rare but potentially fatal brain disease. Sales resumed last year when regulators decided its efficacy outweighed the risks for some patients; tough guidelines were drawn up to help ensure safety.
Now, the UK's National Institute for Health and Clinical Excellence has reinstated Tysabri on the National Health Services' formulary. The action isn't unexpected, but it's significant because the NHS must begin paying for the drug within three months of a NICE approval. Also, continental drug regulators often follow the UK's lead. Analysts predict sales of the drug could now reach $800 million.
- see this reportÂ on the NHS' endorsement
- read the AFX report on Tysabri's comeback
FDA committee backs Tysabri for Crohn's. Report
After reintroduction, Tysabri builds patient base. Report
FDA allows Tysabri back on market. Report