FDA approves supplemental new drug application for Avycaz

The FDA has accepted a supplemental New Drug Application to update the label for Avycaz following the favorable results of a recent phase 3 trial evaluating safety and efficacy, according to a press release from the drug’s manufacturer.

Avycaz (ceftazidime-avibactam, Allergan) is to be used in combination with metronidazole for the treatment of complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs), including kidney infections. The antibiotic’s initial approval in February 2015 lacked phase 3 study data, and was based exclusively on the safety and efficacy data of ceftazidime as well as in vitro studies and animal models of avibactam.

“[cIAIs] represent a major therapeutic challenge for physicians,” David Nicholson, PhD, chief R&D officer at Allergan, said in a press release. “Avycaz has been used in thousands of patients with these difficult-to-treat infections since it was first approved by the FDA in February 2015. The addition of these data to the label provides physicians with consistent evidence of the activity of Avycaz against some of the most challenging pathogens, including those for which we currently have limited treatment options.”

According to the press release, the phase 3 study found combination ceftazidime-avibactam/metronidazole to be noninferior to meropenem. In addition, the treatment was unhampered by ceftazidime-resistant pathogens and certain extended spectrum beta-lactamases.

Common adverse events with ceftazidime-avibactam include diarrhea, naseu, constipation and anxiety.

Disclosure: Nicholson is an employee of Allergan.