tysabri lawyer

Sep 27, 2012 by breannamcm73

U.S. regulators have extended their review of Biogen Idec Inc’s application to update the prescribing data for its numerous sclerosis drug Tysabri, the business stated on Thursday.

Biogen, which sells the drug with Irish drugmaker Elan Corp Plc, is searching for to add info to the drug’s label to show that measuring a patient’s antibodies to the JC virus can assist assess the risk of a patient producing progressive multifocal leukoencephalopathy, a potentially deadly brain disease.

The JC virus is believed to cause PML.

Tysabri, regarded as the most useful numerous sclerosis drug on the market, has been beset by concerns that it can result in PML, particularly over time. Biogen is seeking to implement a danger-stratification plan, showing that patients who test negative for the JC virus are far much less likely to create PML than those who test positive.

Biogen mentioned the U.S. Food and Drug Administration indicated that the extension of the assessment is needed to allow much more time to assessment alterations being incorporated into the risk evaluation and mitigation strategies (REMS) system for Tysabri, to be consistent with the anticipated prescribing info.

Weston, Massachusetts-based Biogen mentioned FDA’s three-month extension is a standard extension period.

Speak to a Tysabri lawyer about your potential Tysabri claim.