FDA Approves New Combo Antibacterial Drug

The FDA announced the approval of a new antibacterial drug designed to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI)—including kidney infections—who have limited or no alternative options for treatment.

The fixed-combination drug, Avycaz, contains ceftazidime (an approved cephalosporin drug), and avibactum (a beta-lactamase inhibitor).
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To determine it’s efficacy, researchers evaluated the drug in 2 Phase 2 trials—1 in cUTI and 1 in cIAI.

Previous data collected on the efficacy of ceftazidime, which treats cIAI and cUTI, also helped researchers determine Avycaz’s safety and efficacy.

According to researchers, the most common side effects include anxiety, constipation, nausea, and vomiting. Healthcare workers are urged to inform patients of those risk and more adverse events including seizures and neurological events in patients with renal impairment, and serious skin reactions or anaphylaxis could occur in those with allergies to penicillin.

The complete press release is available on the FDA’s website.

-Michelle Canales Butcher

Reference:

US Food and Drug Administration. FDA approves new antibacterial drug Avycaz. February 25, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435629.htm. Accessed February 27, 2015.