The U.S. Food and Drug Administration today 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.
Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor.
"The FDA is committed to making therapies available to treat patients with unmet medical need," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient's infection."
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.
As part of its QIDP designation, Avycaz was given priority review, which provides an expedited review of the drug's application. The QIDP designation also qualifies Avycaz for an additional five years of marketing exclusivity to be added to the five-year exclusivity period provided by the Food, Drug, and Cosmetic Act.
The determination of 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 thatdecreased 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.