FDA Advisory Committee recommends reintroduction of Tysabri for treatment of relapsing forms of MS

Published: 9-Mar-2006
Regulatory

The Peripheral and Central Nervous System Drugs Advisory Committee of the US FDA has voted unanimously to recommend reintroduction of Tysabri (natalizumab), developed by Biogen Idec and Elan Corporation as a treatment for relapsing forms of multiple sclerosis (MS).


The Peripheral and Central Nervous System Drugs Advisory Committee of the US FDA has voted unanimously to recommend reintroduction of Tysabri (natalizumab), developed by Biogen Idec and Elan Corporation as a treatment for relapsing forms of multiple sclerosis (MS).

The Committee's recommendation is advisory, and the FDA is not bound by this recommendation. However, the FDA has designated Tysabri for Priority R-view, a status gratned to products that are considered to be significant therapeutic advancements over existing therapies that address an unmet medical need.

Biogen Idec and Elan will continue to work closely with the FDA in the weeks ahead, including finalising the details of the Tysabri risk management plan.

The companies expect action by the FDA by the end of this month.

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