Macro Tsimmis

intelligently hedged investment

Élan (ELN) update #7

Posted by intelledgement on Mon, 14 Jan 08

Élan announced today that the FDA has approved tysabri for use by patients in the USA with moderate-to-severe Crohn’s disease. The press release stated, “TYSABRI is now approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.… TYSABRI will be available to Crohn’s patients by the end of February 2008.”

There are an estimated 500,000 people in the USA who suffer from CD. As tysabri is envisaged only as a treatment of last resort, the effect on sales is expected to be modest. Tysabri is primarily used by multiple sclerosis patients; Élan announced last week that there are now 21,000 total patients using the drug, which is in line with projections of 100,000 users by the end of 2010.

Late last year, EMEA decided against making tysabri available for CD patients in Europe. ELN and their partner Biogen Idec (BIIB) are currently appealing that decision; tysabri is approved both in Europe and the USA for use by multiple sclerosis patients.


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