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Biogen, Elan say FDA committee votes to reintroduce Tysabri for multiple sclerosis
By Jennifer Chiou
New York, March 8 - Biogen Idec and Elan Corp. plc said they have received notification from the Food and Drug Administration that the Peripheral and Central Nervous System Drugs Advisory Committee has unanimously recommended the reintroduction of Tysabri (natalizumab) for the treatment of multiple sclerosis.
However, the FDA is not bound by the committee's recommendation, the companies added.
Biogen and Elan said they will discuss, among other things, a risk management plan for Tysabri with the FDA by March 29.
On Jan. 23, the companies announced they received notification from the FDA that the committee would review Tysabri on March 7.
On Sept. 26, the companies submitted to the FDA a supplemental Biologics License Application for Tysabri and the FDA designated it for priority review.
The FDA grants priority review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need.
The sBLA includes two-year data from the phase 3 monotherapy trial and add-on trial with Avonex (Interferon beta-1a) in multiple sclerosis, a revised label and risk management plan and an integrated safety assessment of Tysabri clinical trial patients, officials previously said.
Biogen Idec and Elan previously completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in progressive multifocal leukoencephalopathy and multiple sclerosis.
The results yielded no new confirmed cases of progressive multifocal leukoencephalopathy beyond the three previously reported, officials had said.
Biogen Idec is a Cambridge, Mass., biopharmaceutical company that develops, manufactures and commercializes new therapies with a focus on oncology, neurology and immunology.
Elan is a Dublin, Ireland, neuroscience-based biotechnology company.
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