Thursday, January 17, 2013

Biogen Idec and Elan seek label expansion for Tysabri for first line use in Multiple Sclerosis

Biogen Idec and Elan have filed for approval for Tysabri as first-line treatment for relapsing forms of MS in anti-JC virus (JCV) antibody negative patients. The PDUFA date for the sBLA to expand Tysabri's label is in 2H-2013. Currently Tysabri is  used in patients who are not responding to or who are unable to tolerate an alternative therapy.  From an efficacy perspective, Tysabri is the most potent among all existing treatment options.

MS Patients with anti-JCV antibody positive status treated with Tysabri are at an increased risk of developing progressive multifocal leukoencephalopathy (PML). Earlier this year, both the U.S. and EU updated Tysabri labels to reflect the same.
According to Biogen and Elan, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider Tysabri early in the course of treatment, regardless of the level of disease activity or prior treatment history

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