Carbavance Gets Priority Review for Complicated UTI

FDA to review Carbavance for complicated urinary tract infections
FDA to review Carbavance for complicated urinary tract infections

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) of Carbavance (meropenem-vaborbactam; The Medicines Company) for the treatment of complicated urinary tract infections (cUTIs).

The NDA submission was supported by data from TANGO 1, a Phase 3 clinical trial evaluating Carbavance in patients with cUTIs. The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%, demonstrating statistical superiority over piperacillin-tazobactam. 

Additional interim data from TANGO 2, an ongoing Phase 3 study comparing the safety, tolerability and efficacy of Carbavance with best available antibiotics in patients with carbapenem-resistant Enterobacteriaceae (CRE) infections, also supported the NDA.

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Carbavance is an investigational injectable antibiotic combining the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (RPX7009), for the potential treatment of serious gram-negative infections, including those caused by CRE.

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