FDA Approves Actavis Superbug Antibiotic Avycaz

The FDA has approved Actavis’ Avycaz, a new antibiotic for adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections.

Avycaz (ceftazidime-avibactam) is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial, and avibactam, a new beta-lactamase inhibitor. It is used in combination with metronidazole to treat abdominal infections. Clinical evaluation of Avycaz included two Phase II trials, one each for abdominal and urinary tract infections, that demonstrated efficacy and safety in both conditions, the FDA said.

The most common side effects of the drug were nausea, vomiting, constipation and anxiety. However, lower efficacy, seizures and other neurologic events were seen in patients with impaired kidney function, the agency says.

Avycaz was granted priority review and approval as a qualified infectious disease treatment under the Generating Antibiotics Incentives Now Act. The designation comes with an extra five years of market exclusivity.

Actavis plans to roll out the drug in the second quarter. It will be distributed by Forest Pharmaceuticals, a subsidiary of Forest Laboratories. — Jonathon Shacat