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tysabri lawyer

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

Biogen, which sells the drug with Irish drugmaker Elan Corp Plc, is seeking to add details to the drug’s label to show that measuring a patient’s antibodies to the JC virus can support assess the danger of a patient creating progressive multifocal leukoencephalopathy, a potentially deadly brain illness.

The JC virus is thought to result in PML.

Tysabri, thought to be the most efficient many sclerosis drug on the industry, has been beset by issues that it can cause PML, specially more than time. Biogen is searching for to implement a risk-stratification system, showing that patients who test negative for the JC virus are far less most 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 permit far more time to evaluation modifications becoming incorporated into the threat evaluation and mitigation techniques (REMS) program for Tysabri, to be constant with the anticipated prescribing details.

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

Speak to a Tysabri lawyer about your potential Tysabri claim.