(Updates with details, analyst comment)
LONDON/BOSTON, July 19 (Reuters) - European drug regulators have recommended against the use of Tysabri, a multiple sclerosis drug made by Biogen Idec Inc. (BIIB.O) and Elan Corp. ELN.I, as a treatment for Crohn’s disease.
The European Medicines Agency said on Thursday the risk of serious infection outweighs the relatively modest benefit conferred by the drug on Crohn’s patients.
Cambridge, Massachusetts-based Biogen and Elan, which is based in Ireland, said they will appeal the decision and expect a ruling on the appeal by the first quarter of 2008.
Tysabri was taken off the market in 2005 after being linked with three cases of a potentially deadly brain infection known as progressive multifocal leukoencephalopathy, or PML. It was reintroduced a year ago and is available in the United States through a safety-monitoring program known as TOUCH.
“We are not surprised by this recommendation given the risk that Crohn’s patients present for PML and especially because there is not a TOUCH-like program in Europe,” said Corey Davis, an analyst at Natexis Bleichroeder, in a research note.
Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract that affects about one million people worldwide.
The product will be reviewed by U.S. experts for use in Crohn’s at an advisory meeting on July 31, but Davis said he does not expect it to win approval, despite the U.S. TOUCH program.
“Even if it does receive approval in the U.S., it will represent a small commercial opportunity as Biogen and Elan would only go after a niche part of the market,” he said.
(Reporting by Ben Hirschler and Toni Clarke)
((Editing by Tim Dobbyn; Reuters Messaging, firstname.lastname@example.org, 617-367-4165)) Keywords: ELAN NATALIZUMAB/
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