Conclusion

1
Conclusion
Manfred Haehl, MD

• Senior Vice President Medical Drug
  Regulatory AffairsBoehringer Ingelheim
  Pharmaceuticals, Inc.Ridgefield, Connecticut

2
AGGRENOXConclusion

• AGGRENOX represents a therapeutic advance to the
  secondary prevention of stroke that builds on the
  clinical experience with its components
• The findings both ex vivo and in vivo are
  consistent with additive beneficial effects of
  aspirin and dipyridamole

3
AGGRENOXConclusion

• ESPS-2 provides compelling evidence of the safety
  and efficacy of AGGRENOX that can be
  generalized to clinical practice
• ESPS-2 is robust and eliminates concerns
  regarding chance or bias as the basis for the
  findings
• ESPS-2 meets the requirements for a single trial
  to support approvability

4
AGGRENOXConclusion

• The factorial and pairwise comparisons support
  the conclusion that in the secondary prevention
  of stroke
• AGGRENOX
• is significantly superior to aspirin or extended
  release dipyridamole alone and
• has a favorable benefit-risk ratio

5
AGGRENOXConclusion

• AGGRENOXTM 59 stroke events prevented per 1000
  patients treated for 2 years
• vs
• ASA 30 events prevented per 1000 patients
  treated for 2 years
• vs
• DP-ER 26 events prevented per 1000 patients
  treated for 2 years

6
AGGRENOXConclusion

• Based on the positive trend for a mortality
  benefit consistent with the aspirin label and the
  inclusion of an FDA-approved daily dose of
  aspirin,
• it is appropriate from a scientific and
  regulatory perspective to afford AGGRENOXTM the
  same label indication as aspirin

7
AGGRENOXConclusion

• ESPS-2 establishes AGGRENOXTM as firstline
  therapy for secondary prevention of stroke and
  its labeling should describe its superiorityto
  aspirin

8
Conclusion
Manfred Haehl, MD

• Senior Vice President Medical Drug
  Regulatory AffairsBoehringer Ingelheim
  Pharmaceuticals, Inc.Ridgefield, Connecticut