represents our current understanding in the profile of Saxagliptin. Both BMS and
AstraZeneca are committed to the continued assessment of the benefit risk profile of
Saxagliptin post-approval. The assessment of the post-approval profile of Saxagliptin
will be achieved through three approaches; A comprehensive sweep of a post-marketing
pharmacovigilance practices, the analysis of observational data, and the analysis of
randomized clinical trial data.
up to two and a half years. In these meta-analyses we did not see a cardiovascular
safety signal for Saxagliptin. Thus, Saxagliptin provides meaningful benefits on
glycemia control with a favorable safety profile. Compared with several of the available
agents for type 2 diabetes, Saxagliptin provides an improved tolerability and safety
profile with respect to hypoglycemia, weight gain, gastrointestinal adverse events, heart
failure and edema. Saxagliptin offers a new treatment option with a favorable benefit
risk profile for patients with type 2 diabetes.
evaluation of individual spontaneous safety reports and enhanced by the use of targeted
questionnaires like those used during our phase 3 program. Also, there will be periodic
assessments of the aggregate safety data compared with the FDA errors database for
safety signal detection. A large pharmacoepidemiology program will use observational
Post marketing pharmacovigilance practices include the collection and
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
ASSESSMENT OF SAXAGLIPTIN POST-APPROVAL
BRIAN DANIELS, M.D.
Thanks Bob. The positive benefit risk discussion Dr. Wolf just presented
Medical Affairs at Bristol Myers-Squibb, will now describe our plan to continue to assess
Saxagliptin if it is approved for clinical use in the United States.
Dr. Brian Daniels, Senior Vice President for Global Development and