Tysabri lawsuit

Jul 22, 2012 by gerardofor65

U.S. regulators have extended their assessment of Biogen Idec Inc’s application to update the prescribing information for its multiple sclerosis drug Tysabri, the firm said on Thursday.

Biogen, which sells the drug with Irish drugmaker Elan Corp Plc, is looking for to add information to the drug’s label to show that measuring a patient’s antibodies to the JC virus can help assess the threat of a patient creating progressive multifocal leukoencephalopathy, a potentially deadly brain disease.

The JC virus is thought to result in PML.

Tysabri, thought to be the most successful many sclerosis drug on the industry, has been beset by issues that it can trigger PML, especially more than time. Biogen is searching for to implement a risk-stratification program, showing that patients who test negative for the JC virus are far much less likely to develop PML than those who test positive.

Biogen stated the U.S. Food and Drug Administration indicated that the extension of the evaluation is necessary to enable more time to evaluation adjustments getting incorporated into the threat evaluation and mitigation tactics (REMS) plan for Tysabri, to be constant with the anticipated prescribing information.

Weston, Massachusetts-based Biogen stated FDA’s 3-month extension is a normal extension period.

Speak to a Tysabri lawyer about your potential Tysabri claim.