FDA fast-track status for investigational antibiotic Carbavance

US drugmaker The Medicines Company (Nasdaq: MDCO) has been granted fast-track designation by the Food and Drug Administration for its investigational agent Carbavance (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTI).

Carbavance is the combination of the carbapenem antibiotic, meropenem, with the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), that is being developed for the treatment of gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE).

The Medicines Company acquired rights to Carbavance along with its takeover Rempex Pharmaceuticals, in a deal worth a potential $474 million to the latter’s shareholders, of which $140 million was paid upfront (The Pharma Letter December 4, 2013).