DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced that the U.S. Food and Drug Administration (FDA) informed the companies that the Agency will extend its regulatory review of TYSABRI® (natalizumab) as a treatment for Crohn’s disease by up to 3 months.
The companies have been informed by the FDA that the Agency requires additional time to review information regarding the proposed TYSABRI risk management plan for Crohn’s disease. Under this revised timeline, the companies anticipate action from FDA on or before January 13, 2008.
