New Combination Antibacterial Drug Avycaz Approved

New Drugs , News / October 4, 2016

The FDA approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole; and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

Avycav is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor.

Avycaz is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

The efficacy of Avycaz was supported in part by the findings of the efficacy and safety of ceftazidime for the treatment of cIAI and cUTI. The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection.  Avycaz was studied in two Phase 2 trials, one each in cIAI and cUTI. Both trials were not designed with any formal hypotheses for inferential testing against the active comparators.

The most common side effects include vomiting, nausea, constipation and anxiety. Health care professionals should inform patients of these risks and also advise that decreased efficacy, seizures and other neurologic events were seen in patients with poor kidney function (renal impairment). Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

Avycaz is distributed by Forest Pharmaceuticals Inc., a subsidiary of Forest Laboratories Inc. based in Cincinnati, Ohio.

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