First BARDA-developed treatment for drug-resistant bacteria receives FDA approval

The U.S. Food and Drug Administration (FDA) recently approved the use of Vabomere, the first antibiotic drug in the Biomedical Advanced Research and Development Authority (BARDA) portfolio, in order to help combat the rise of drug-resistant bacteria.

Specifically, Vabomere was approved to treat complications from urinary tract infection and a type of kidney infection known as pyelonephritis in adults. It also was approved to address gram-negative bacteria that produce beta-lactamase enzymes, like the Klebsiella pneumoniae carbapenemase (KPC enzyme), which have increasingly spread throughout the United States and Europe.

According to the U.S. Centers for Disease Control and Prevention (CDC), the spread of KPC bacteria is known to cause a large majority of all carbapenem-resistant Enterobacteriaceae (CRE) in the United States and is classified as a public health threat due to its high levels of antibiotic resistance.

Vabomere now becomes the 32nd BARDA-supported medical countermeasure to achieve licensure or approval from the FDA.

In addition to the drug’s approval, BARDA has been working in tandem with industry stakeholders to develop a public-private partnership called CARB-X that aims to promote innovative antibacterial product developments and reduce the barriers of entry to any company willing to develop treatments for drug resistance.