Drug Development

U.S. FDA accepts supplemental application for Tysabri in multiple sclerosis

Published in Drug Week, December 16th, 2005

Biogen Idec (BIIB) and Elan Corp., plc (ELN) announced that the supplemental Biologics License Application (sBLA) for Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) has been accepted and designated for priority review by the U.S. Food and Drug Administration (FDA).

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. Based on the FDA's designation of priority review for Tysabri in MS, the companies anticipate action by the agency approximately 6 months from the submission date, rather than 10 months for a standard...

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Source: Drug Week (2005-12-16)

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