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Alexion Pexelizumab Failed CABG Trial Could Support Acute MI Claim – Firm

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Alexion’s failed pexelizumab Phase III coronary artery bypass graft surgery trial could serve as a supportive trial for an acute myocardial infarction indication, the firm says.

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Alexion pexelizumab fails second PRIMO study

Alexion's terminal complement inhibitor pexelizumab fails to show statistical significance in the firm's second coronary artery bypass graft trial, PRIMO-CABG2. Alexion is assessing the implications of the results on its APEX-AMI study of the biologic in acute myocardial infarction. When pexelizumab failed the first PRIMO (Pexelizumab for Reduction in Infarction & Mortality) study in August 2003, Alexion said the results could be used to support an AMI indication (Pharmaceutical Approvals Monthly September 2003, p. 21). The APEX study has enrolled 3,000 patients, according to the firm...

Alexion pexelizumab fails second PRIMO study

Alexion's terminal complement inhibitor pexelizumab fails to show statistical significance in the firm's second coronary artery bypass graft trial, PRIMO-CABG2. Alexion is assessing the implications of the results on its APEX-AMI study of the biologic in acute myocardial infarction. When pexelizumab failed the first PRIMO (Pexelizumab for Reduction in Infarction & Mortality) study in August 2003, Alexion said the results could be used to support an AMI indication (Pharmaceutical Approvals Monthly September 2003, p. 21). The APEX study has enrolled 3,000 patients, according to the firm...

Alexion pexelizumab Phase III trials

Alexion and partner Procter & Gamble will conduct a confirmatory Phase III coronary artery bypass graft surgery trial with pexelizumab as well as a pivotal Phase III trial in acute myocardial infarction in "upcoming months." The company downplayed the need for an additional CABG trial when it presented results from the failed Phase III PRIMO-CABG trial, suggesting that the initial trial could support the AMI indication (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 21). Alexion presented a meta-analysis at the American College of Cardiology Scientific Sessions on March 8, showing a significant reduction of 30-day mortality in pooled data from the Phase II AMI trials and the Phase II and Phase III CABG trials, although results were not significant in any of the individual studies...

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