FDA Accepts Priority Review NDA for Carbavance

FDA has accepted for priority review an NDA from the Medicines Co. for Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections (cUTIs). The submission is based on results from the pivotal Phase 3 TANGO 1 clinical trial in patients with cUTIs, which met both FDA and European Medicines Agency pre-specified primary endpoints, according to the company. “Carbavance also demonstrated statistical superiority over piperacillin-tazobactam with overall success in 98.4% of patients,” it says.

Carbavance is a combination of carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), administered as a fixed combination by intravenous infusion. It is being developed to treat serious gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently-available carbapenems.