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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

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.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....