Tysabri’s Tally of PML Cases Reaches 13

9/17/09Follow @xconomy

Biogen Idec and Elan’s fast-growing multiple sclerosis drug, natalizumab (Tysabri), has been connected to 13 cases of a potentially fatal brain infection, according to an FDA notice reported on today by Bloomberg News.

Cases of progressive multifocal encephalopathy, or PML for short, have been adding up since the drug was re-introduced to the U.S. market in July 2006 after it was withdrawn because of the risk. Despite the chance of infection, which the FDA pegged at about 1 in 1,000, patients have continued to seek out the treatment, which physicians say is the most effective therapy on the market for multiple sclerosis. More than 40,000 people worldwide were taking the drug at the end of March, according to Cambridge, MA-based Biogen (NASDAQ: BIIB).

Behind the scenes, researchers have intensified efforts to find out what it is about natalizumab that might be making people vulnerable to this particularly dangerous brain infection, and how to treat it. One Harvard Medical School neurologist, Igor Koralnik, presented research last week at at a European medical meeting that suggested patients’ immune system T cells didn’t work as well against the virus linked to PML when they were on the MS treatment, according to a separate Bloomberg report. Biogen said the results weren’t definitive.

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  • http://www.nyas.org/PML Kristy Kilpin

    In response to Luke Timmerman’s recent report on natalizumab (Tysabri)connection to 13 cases of a potentially fatal brain infection, I thought there might be interest for interested communities to attend this upcoming event in New York City on November 10th:

    Tuesday, November 10, 2009 (8:00am-5:30pm)
    Immunomodulating Therapies and Progressive Multifocal Leukoencephalopathy (PML)

    The aim of this symposium is to provide a forum to discuss whether Progressive multifocal leukoencephalopathy (PML) that has been seen in multiple drug trails is a direct consequence of the mechanism of therapeutic action or whether it’s an off-target adverse affect of the therapeutic agent. http://www.nyas.org/PML. Sponsored by the New York Academy of Sciences.