 |
Update: March 22, 2006— Biogen Idec and Elan Corporation announced today that the U.S. Food and Drug Administration (FDA) informed them that the Agency will extend its regulatory review of Tysabri® (natalizumab) as a treatment for multiple sclerosis by up to 90 days.
According to the companies, the Agency needs to further review information on the proposed risk management plan. (The drug was withdrawn from the market as a therapy for relapsing MS in February 2005 due to safety concerns.) Tysabri is now being re-evaluated by the FDA for its possible return to market. On March 8, 2006 the FDA advisory panel recommended to the FDA its return. According to the companies, under this revised review timeline, they anticipate action from the FDA on or before June 28, 2006.
Source: USA National MS Society
Weblink: click here
|
