Cubist To Seek Cubicin sNDA Priority Review For Endocarditis, Bacteremia
This article was originally published in Pharmaceutical Approvals Monthly
Cubist plans to request a priority review for an sNDA it will submit by year-end for use of its Cubicin antibiotic for endocarditis and bacteremia
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Pivotal data for Cubist's Cubicin treatment of endocarditis/bacteremia show comparable efficacy to standard care with superior renal safety, the firm reported Dec. 16
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...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011