CHICAGO, IL, (NAMC) – On Monday Biogen Idec (NASDAQ:
BIIB) and Elan Corporation, plc. (NYSE:
ELN) made an announcement that the companies received notification from the U.S. Food and Drug Administration (FDA) that the Peripheral and Central Nervous System Drugs Advisory Committee will review TYSABRI(R) (natalizumab) for the treatment of multiple sclerosis (MS) on March 7, 2006.
On September 26, 2005 the companies announced that they submitted to the FDA a supplemental Biologics License Application (sBLA) for TYSABRI. Subsequently, the FDA designated TYSABRI 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. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, or by late March 2006.
Peter Farrell
Business News Correspondent
NAMC Newswire
www.namcnewswire.com This article can be republished either online or in print as long as credit is given to the author and the NAMC Newswire.
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