BOSTON, Aug 28 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) said on Tuesday that as of mid-July there have been no new reported cases of a potentially deadly brain infection in patients taking its multiple sclerosis drug Tysabri.
The Cambridge, Massachusetts-based biotechnology company made the disclosure as part of a slide presentation for a conference in Belgium.
According to the slide, there have been no new reports of progressive multifocal leukoencephalopathy, or PML, a rare brain disease since mid-July, which means there have been no new reports of the disease since the drug was reintroduced to the market a year ago. Tysabri, developed with Irish drugmaker Elan Corp. (ELN.I: Quote, Profile, Research), was taken off the market in 2005 after being linked with three cases of the infection. The U.S. Food and Drug Administration allowed the drug back last July because it is effective and patients asked for it to be returned.
Through mid-July, 2007, there were about 14,000 patients taking Tysabri worldwide, of which roughly 12,900 were commercial patients and 1,000 clinical trial patients.
Tysabri is available in the United States through a safety-monitoring program known as TOUCH. All prescribers, infusion sites and patients are required to enroll in the program, which is designed to monitor patients for any signs or symptoms of PML.
(Reporting by Toni Clarke)
((Editing by Dave Zimmerman, Reuters Messaging, toni.clarke.reuters.com@reuters.net, 617-367-4165)) Keywords: BIOGEN TYSABRI
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