http://www.fda.gov/ohrms/dockets/ac/07/ ... Errata.pdf
MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE - FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH
DATE: July 20, 2007
TO: Participants at the Joint meeting between the Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007
"The Division of Gastrointestinal Products and the Office of Surveillance and Epidemiology provide the following corrections to the original background package submitted for the Tysabri (natalizumab) advisory committee meeting scheduled for July 31, 2007.
[The] FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies (e.g., as second- line therapy).
However, the indication statement does not explicitly preclude the possibility of firstline therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient