News & Events
FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Statement On Tysabri Review Time
Biogen Idec and Elan announced on March 22, 2006, that the Food and Drug Administration (FDA) had extended the regulatory review period for the reintroduction of Tysabri (natalizumab) for multiple sclerosis (MS) by up to 90 days.
Under the Prescription Drug User Fee Act, extensions to the review period for an application can be triggered by a substantive submission from the sponsor. In this case, the information received was determined to be a major amendment to the pending application. The review period for the application was extended by up to 90 days to provide FDA time to review the new information.
This new submission is a revised Risk Management Plan (RMP), which takes into account the issues discussed, and recommendations offered, by the Peripheral and Central Nervous System Drugs Advisory Committee on March 7th and 8th of this year. Both the company and FDA believe that a RMP is important to help ensure safe use of the product.
This application continues to be a high priority. The agency is working intensively to complete review of this new information and will attempt to do so before the end of the 90 day extension period.