X hits on this document

419 views

0 shares

0 downloads

0 comments

58 / 170

14

represents our current understanding in the profile of Saxagliptin. Both BMS and

15

AstraZeneca are committed to the continued assessment of the benefit risk profile of

16

Saxagliptin post-approval. The assessment of the post-approval profile of Saxagliptin

17

will be achieved through three approaches; A comprehensive sweep of a post-marketing

18

pharmacovigilance practices, the analysis of observational data, and the analysis of

19

randomized clinical trial data.

1

up to two and a half years. In these meta-analyses we did not see a cardiovascular

2

safety signal for Saxagliptin. Thus, Saxagliptin provides meaningful benefits on

3

glycemia control with a favorable safety profile. Compared with several of the available

4

agents for type 2 diabetes, Saxagliptin provides an improved tolerability and safety

5

profile with respect to hypoglycemia, weight gain, gastrointestinal adverse events, heart

6

failure and edema. Saxagliptin offers a new treatment option with a favorable benefit

7

risk profile for patients with type 2 diabetes.

21

evaluation of individual spontaneous safety reports and enhanced by the use of targeted

22

questionnaires like those used during our phase 3 program. Also, there will be periodic

23

assessments of the aggregate safety data compared with the FDA errors database for

24

safety signal detection. A large pharmacoepidemiology program will use observational

57

20

Post marketing pharmacovigilance practices include the collection and

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

11

ASSESSMENT OF SAXAGLIPTIN POST-APPROVAL

12

BRIAN DANIELS, M.D.

13

Thanks Bob. The positive benefit risk discussion Dr. Wolf just presented

9

Medical Affairs at Bristol Myers-Squibb, will now describe our plan to continue to assess

10

Saxagliptin if it is approved for clinical use in the United States.

8

Dr. Brian Daniels, Senior Vice President for Global Development and

Document info
Document views419
Page views419
Page last viewedSat Dec 03 07:16:24 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments