Dear Members, Consultants,
Speakers, and Guests:
Thank you for your
willingness to participate in the September 10, 2004 Cardio-Renal Drugs
Advisory Committee meeting regarding ExantaÒ (ximelagatran) Tablets for the following
indications:
1. Prevention of venous thromboembolism (VTE) in
patients undergoing knee replacement surgery
2. Prevention
of stroke and other thromboembolic complications associated with atrial
fibrillation
3. Long term secondary prevention of VTE after standard
treatment for an episode of acute VTE
We are providing you an
Integrated Executive Summary with issues for committee consideration. In this background package, we also provide
the draft reviews of the New Drug Application (NDA) from the Food and Drug
Administration (FDA) medical, statistical, and Office of Drug Safety
reviewers. The FDA background package
often includes initial reviews and/or preliminary conclusions and
recommendations written by individual FDA reviewers. These conclusions and recommendations do not
necessarily represent the final position of the individual reviewer, nor do
they necessarily represent the final position of the FDA. The FDA will not take a final action on the
application until input from the advisory committee has been considered and all
reviews have been finalized.
In order to aid your review
of the documents provided by the FDA and AstraZeneca LP, we would like to focus
on the following topics:
·
Safety of
short-term and long-term use, particularly with regard to hepatotoxicity
·
Adequacy of the
sponsor’s proposed risk management program for hepatotoxicity
·
Possible
increased risk of myocardial infarction/coronary artery disease
·
Benefit risk
assessment for the use of Exanta (ximelagatran) in each indication
The following items are
attached:
1. Integrated Executive Summary
2. Draft
Medical Officer Review, Division of Gastrointestinal and Coagulation Drug
Products
3. Draft Statistical Review, Division of
Biometrics II
4. Draft Medical Officer Review, Division of
Cardio-Renal Drug Products
5. Draft Statistical Review, Division of
Biometrics I
6. Draft Review, Office of Drug Safety
7. Clinical White Paper, CDER-PhRMA-AASLD
Conference, November 2000
The final questions will be
given to you prior to the actual meeting.
We look forward to your
participation and to a productive meeting on
Sincerely,
Robert
L. Justice, M.D., M.S.
Director
Division
of Gastrointestinal and Coagulation Drug Products
Center
for Drug Evaluation and Research
Food
and Drug Administration