Posted by Jacob Goldstein
Tysabri, the multiple sclerosis drug that was withdrawn temporarily from the market after reports of serious brain infections, hasn’t been connected with any such infections since shipments resumed last July, the latest data show.
Biogen Idec, which co-markets the drug with Elan, made the update in a securities filing today. Since the companies resumed selling the drug, there have been “no confirmed cases of PML or other serious opportunistic infections,” according to a single PowerPoint slide Biogen Idec filed with the SEC. The filing occurred in advance of a presentation today at a neurology meeting in Greece.
Tysabri was approved in late 2004 then withdrawn in early 2005, after it emerged that three people in clinical trials of the drug developed PML, or progressive multifocal leukoencephalopathy, a very rare, very serious infection of the brain. As of May 23rd of this year, about 12,000 patients worldwide were on the drug, including about 7,600 in this country.
The agreement the company worked out with the FDA — described here — suggests the agency will continue to scrutinize the drug. The agreement requires the company monitor all patients on the drug, and to report to the FDA every quarter for the first year, every six months for the next two years, and annually after that. If any cases of PML or other serious opportunistic infections emerge, they must be reported within 15 days. [标签:content1][标签:content2]
作者:admin@医学,生命科学 2011-03-24 21:21