FDA Approves Avycaz Supplemental NDA for Pneumonia
The approval for Avycaz comes following the results of a successful phase 3 clinical trial.
The US Food and Drug Administration approved the supplemental New Drug Application for the antibiotic Avycaz® (ceftazidime and avibactam; Allergan) to expand the drug's use to treat adults with hospital-acquired or ventilator-associated bacterial pneumonia.
The approval follows the results of a phase 3, multinational, double-blind clinical trial (REPROVE; ClinicalTrials.gov Identifier: NCT01808092) that compared Avycaz 2.5 g (ceftazidime 2 g and avibactam 0.5 g) given intravenously every 8 hours with meropenem 1 g also given intravenously every 8 hours for 7 to 14 days. Dosages were modified per renal function. Prior and concomitant systemic antibacterial therapy could be administered in patients with proven or suspected Gram-positive or drug-resistant infections.
The study's primary efficacy end point was 28-day all-cause mortality in the intent-to-treat population. The mortality rate was 9.6% in patients treated with Avycaz compared with 8.3% in patients treated with meropenem (treatment difference, 1.5%; 95% CI, -2.4 to 5.3). With respect to the primary end point, Avycaz demonstrated noninferiority to meropenem. The safety profile was consistent with that of previously reported clinical trials that evaluated Avycaz and the established safety of ceftazidime alone. The most common adverse reactions were diarrhea and vomiting.
New treatment strategies to fight bacterial pneumonia are needed, as certain types of Gram-negative bacteria have become increasingly resistant to antibiotics.
In 2015, Avycaz was approved to treat adults with complicated intra-abdominal infections in combination with metronidazole and more recently to treat complicated urinary tract infections including kidney infections.
FDA approves Avycaz® (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia [press release]. Dublin, Ireland: Allergan; February 1, 2018. Accessed February 2, 2018.