The FDA has designated The Medicines Company‘s Carbavance as a Qualified Infectious Disease Product (QIDP). This designation provides Carbavance priority review by the FDA, eligibility for Fast Track status, and an additional five years of exclusivity upon approval of the product for intravenous use in six indications. These include complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutropenia.

The QIDP designation was granted pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in 2012. Carbavance is an investigational agent that is a combination of a novel beta-lactamase inhibitor (RPX7009) with a carbapenem for intravenous treatment of hospitalized patients with serious infections. RPX7009 is the first of a novel class of beta-lactamase inhibitors designed by Rempex Pharmaceuticals, a wholly owned subsidiary of The Medicines Company, to inhibit the KPC (Klebsiella pneumoniae carbapenemases) enzyme, the primary resistance mechanism to carbapenems. Carbavance has completed Phase I dose-escalation studies in normal subjects, and is expected to enter registration studies in 2014.