FDA. US: 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 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.
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.