New Antibacterial Approved for Complex Infections

The US Food and Drug Administration (FDA) approved a new antibacterial drug combination product ceftazidime-avibactam (Avycaz/Forest Labs). It is for use in patients with complicated intra-abdominal infections. It can also be used in combination with metronidazole and in treating complicated urinary tract infections in those patients who have few alternative treatment options. That includes treating patients with complex kidney infections.

The product contains ceftazimide, an approved cephalosporin, as well as containing avibactam.

The FDA gave its approval under a “Qualified Infectious Disease Product” designation, after giving the product an expedited review.

The designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now program, part of the FDA Safety and Innovation Act.

The designation also gives the manufacturer an additional 5 years of exclusivity in addition to 5 years provided under the Food Drug and Cosmetic Act.

Avycaz went through 2 phase 2 trials: one for the intra-abdominal infection indication and one for its use in urinary tract infections.

Side effects include vomiting, nausea, constipation and anxiety.

In addition, the FDA said, patients with poor kidney function are more likely to see that the drug product is less effective and these patients could also have seizures or other neurologic events.