FDA Approves Label Update for Complicated UTI Treatment
The FDA has approved Allergan’s supplemental new drug application to update the label for their complicated urinary tract infection (cUTI) treatment.
The FDA has approved Allergan’s supplemental new drug application to update the label for their complicated urinary tract infection (cUTI) treatment. Avycaz (ceftazidime and avibactam) is indicated to treat cUTIs, such as pyelonephritis.
The approval is based on 2 phase 3 trials that demonstrated the clinical benefits of the treatment for cUTIs caused by designated susceptible Gram-negative microorganisms. Gram-negative pathogens are classified as urgent and serious public health threats by the CDC, with limited treatment options. The results of the cumulative studies validate the FDA approval of Avycaz as an effective therapy option for patients with cUTIs.
“Gram-negative pathogens are among the most urgent antibiotic resistance threats and cause more than 40,000 resistant infections in the United States alone each year,” David Nicholson, PhD, Chief R&D Officer, Allergan, said in a press release.
Avycaz was first approved by the FDA in February 2015 for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTIs. Avycaz should be used to treat only indicated infections caused by susceptible bacteria.
FDA Approves Allergan’s sNDA for AVYCAZ (ceftazidime and avibactam) to include new phase III data in patients with complicated urinary tract infections (cUTI), Including Pyelonephritis [news release]. Allergan’s website. http://www.allergan.com/NEWS/News/Thomson-Reuters/FDA-Approves-Allergan-s-sNDA-for-AVYCAZ-ceftazidi. Accessed Feb. 2, 2017.