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Conclusion Senior Vice President Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut Manfred Haehl, MD.

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Presentation on theme: "Conclusion Senior Vice President Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut Manfred Haehl, MD."— Presentation transcript:

1 Conclusion Senior Vice President Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut Manfred Haehl, MD

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

3 AGGRENOX™ Conclusion ESPS-2 provides compelling evidence of the safety and efficacy of AGGRENOX™ that can be generalized to clinical practice 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 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 ESPS-2 meets the requirements for a single trial to support approvability

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

5 AGGRENOX TM : 59 stroke events prevented per 1000 patients treated for 2 years AGGRENOX TM : 59 stroke events prevented per 1000 patients treated for 2 yearsvs ASA: 30 events prevented per 1000 patients treated for 2 years ASA: 30 events prevented per 1000 patients treated for 2 yearsvs DP-ER: 26 events prevented per 1000 patients treated for 2 years DP-ER: 26 events prevented per 1000 patients treated for 2 years AGGRENOX™ Conclusion

6 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, 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 AGGRENOX TM the same label indication as aspirin

7 AGGRENOX™ Conclusion ESPS-2 establishes AGGRENOX TM as first line therapy for secondary prevention of stroke and its labeling should describe its superiority to aspirin ESPS-2 establishes AGGRENOX TM as first line therapy for secondary prevention of stroke and its labeling should describe its superiority to aspirin

8 Conclusion Senior Vice President Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut Manfred Haehl, MD


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