FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Vabomere (meropenem/vaborbactam)

Indication:

Treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex in adults aged 18 yr or older.

Mechanism:

Vaborbactam is a nonsuicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases such as K pneumoniae carbapenemase (KPC). Meropenem inhibits bacterial cell wall synthesis.

Dosage:

4 g (meropenem [2g]/vaborbactam [2g]) IV q8hr for up to 14 days.

See full prescribing information for dose adjustment in patients with renal impairment.

Approval:

Approval was based on data from a phase 3 multicenter, randomized, double-blind, double-dummy trial, TANGO-I (n=550), in adults with cUTI, including those with pyelonephritis. Data showed about 98.4% of patients treated with meropenem/vaborbactam IV exhibited cure/improvement in symptoms and a negative urine culture test, compared with 94.3% of patients treated with piperacillin/tazobactam.

Reference:

Loutit JS, et al. Meropenem-vaborbactam (MV) compared with piperacillin-tazobactam (PT) in the treatment of adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP) in a phase 3 randomized, double-blind, double-dummy trial (TANGO 1). Open Forum Infectious Diseases. Vol. 3. No. suppl_1. Oxford University Press, 2016. Presented at the Infectious Diseases Society of America IDWeek. San Diego, CA. October 4-8, 2017.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.