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Cubist Cubicin S. aureus sNDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cubist is requesting a priority review for its Cubicin (daptomycin) sNDA filing for treatment of endocarditis and bacteremia caused by Staphylococcus aureus, the firm says Sept. 26. Cubist previously expressed confidence that its pivotal trial supports a broad label. Cubicin showed higher success rates than comparator therapy in the Phase III trial, although those rates did not reach statistical significance (1Pharmaceutical Approvals Monthly July 2005, p. 5). The data will be presented for the first time at the Interscience Conference on Antimicrobial Agents and Chemotherapy Dec. 16-19 in Washington, D.C...

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