(Reuters) ? U.S. regulators have extended their review of Biogen Idec Inc's application to update the prescribing information for its multiple sclerosis drug Tysabri, the company said on Thursday.
Biogen, which sells the drug with Irish drugmaker Elan Corp Plc, is seeking to add information to the drug's label to show that measuring a patient's antibodies to the JC virus can help assess the risk of a patient developing progressive multifocal leukoencephalopathy, a potentially deadly brain disease.
The JC virus is thought to cause PML.
Tysabri, considered the most effective multiple sclerosis drug on the market, has been beset by concerns that it can cause PML, especially over time. Biogen is seeking to implement a risk-stratification program, showing that patients who test negative for the JC virus are far less likely to develop PML than those who test positive.
Biogen said the U.S. Food and Drug Administration indicated that the extension of the review is needed to allow more time to review changes being incorporated into the risk evaluation and mitigation strategies (REMS) program for Tysabri, to be consistent with the anticipated prescribing information.
Weston, Massachusetts-based Biogen said FDA's three-month extension is a standard extension period.
(Reporting by Toni Clarke in Boston; editing by John Wallace)
Source: http://us.rd.yahoo.com/dailynews/rss/science/*http%3A//news.yahoo.com/s/nm/20111020/hl_nm/us_biogen
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