The Food and Drug Administration (FDA) has moved The Medicines Company’s new drug Carbavance forward, according to a press release issued by the company. The FDA designated Carbavance as a Qualified Infectious Disease Product (QIDP), which gives it FDA priority review and “fast track” status. Additionally, QIDP status allows the company five years of exclusivity when approved. The designation allows six indications that include febrile neutropenia, complicated urinary tract infections, intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.
Clive Meanwell, MD, PhD, Chairman and CEO of The Medicines Company said,
"We believe a priority review and approval will help us bring the novel Carbavance to patients with serious gram negative infections more quickly." He added that Carbavance development advances the company’s mission to serve hospitals, alleviate suffering, and save lives.
Carbavance is a beta-lactamase inhibitor (RPX7009) with carbapenem. Patients with serious infections receive it intraveneously in the hospital. Rempex Pharmaceuticals, a subsidiary of The Medicines Company, introduced RPX7009 as the first in a projected line of beta-lactamase inhibitors. The drug inhibits the Klebsiella pneumoniae carbapenemases (KPC) enzyme, which is resistant to carbapenem. Carbapenem-resistant Enterobacteriaceae (CRE) is known to the Centers for Disease Control (CDC) as a serious antimicrobial threat.
Carbavance registration studies begin this month and end in September 2014. The title of the study is “Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Carbavance (RPX2014/RPX7009) in Subjects With Renal Insufficiency.” RPX7009 in combination with carbapenem is being studied to treat bacterial infections and multi-drug resistant bacteria. The study is interventional in scope and is to include subjects with varying degrees of renal insufficiency and those with normal renal function.
The QIDP designation was signed into law in 2012. It is included in the Generating Antibiotic Incentives Now (GAIN) Act and the FDA Safety and Innovation Act (FDASIA). The FDASIA Act strengthens the FDA’s ability to collect user fees from drug sponsors to fund reviews, promotes innovation, speeds approvals, and enhances the drug supply chain. The FDASIA act and QIDP designation allows the FDA to expedite drug development through review of preliminary clinical evidence, indicating substantial improvement over existing therapies for patients with serious illnesses.