Superbug Antibiotic Lands FDA Approval

FDA announced on Feb. 25, 2015 that it approved the use of Avycaz (ceftazidime-avibactam), Actavis’ antibiotic for drug-resistant bacteria, also called superbugs. The antibiotic is designed to treat adults with complicated intra-abdominal infections (cIAI) when used in combination with the generic antibiotic metronidazole. Avycaz is also designated as a standalone medication to treat complicated urinary tract infections (cUTI).

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor, according to the press release. This marks the fifth approval of an antibacterial drug product that has been designated by FDA as a Qualified Infectious Disease Product (QIDP), a designation which is given to antibacterial products that treat serious or life-threatening infections under FDA Safety and Innovation Act title Generating Antibiotic Incentives Now. A QIDP designation gives new drugs priority review, as well as an additional five-year marketing exclusivity period. The safety and efficacy of the drug was determined through two Phase II trials, one in cIAI and one in cUTI.

This approval comes at a time as the word “superbug” has begun circulating through the media more frequently. In February 2015, seven patients at UCLA Medical Center became infected by a potentially fatal group of superbugs, with hundreds exposed to the bacteria, according to the Huffington Post. In January 2015, NovoBiotic, Northeastern University, and the University of Bonn announced a partnership to discover a new class of antibiotics that was identified via new methods. The class of antibiotics is designed to block a microbes’ ability to build cell walls, killing it and inhibiting the bacteria from becoming resistant.

Source: FDA