Macro Tsimmis

intelligently hedged investment

Élan (ELN) update #2

Posted by intelledgement on Thu, 19 Jul 07

The European Medicines Agency (EMEA) today rejected an application from Élan (ELN) and their partner Biogen Idec (BIIB) to allow the use of  Tysabri as a treatment for Crohn’s disease (CD). Regulators stated that there was “insufficient evidence” of Tysabri’s effectiveness in treating the chronic gastrointestinal inflammatory disease. They cited the risk of dangerous side effects, particularly PML  (progressive multifocal leukoencephalopathy), and concluded that the benefits of Tysabri for CD didn’t outweigh the risks.

ELN and BIIB stated that they would appeal the decision; a verdict on said appeal would be expected in the first quarter of 2008.

Meanwhile, the FDA are still considering ELN’s proposal to offer Tysabri for CD in the USA; an advisory committee meeting is scheduled for 31 July and a final decision is expected by 15 October.

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