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FDA accepts supplemental new drug application seeking to expand Avycaz label
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The FDA has accepted a supplemental New Drug Application to update the label for Avycaz after results from a phase 3 trial indicated the treatment was noninferior to doripenem in patients with complicated urinary tract infections, including pyelonephritis, according to a press release from the drug’s manufacturer.
Avycaz (ceftazidime-avibactam, Allergan) is to be used in combination with metronidazole for the treatment of complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs) caused by susceptible bacteria such as Enterobacteriaceae and Pseudomonas aeruginosa, according to the release.
The FDA has granted the supplemental New Drug Application priority review status based on prior Qualified Infectious Disease Product designation for Avycaz. In June, the FDA accepted a supplemental New Drug Application to update the drug’s label after a phase 3 trial found ceftazidime-avibactam/metronidazole was noninferior to meropenem. The antibiotic’s initial approval in February 2015 lacked phase 3 study data, and was based exclusively on the safety and efficacy data of ceftazidime as well as in vitro studies and animal models of avibactam.
"The initial Avycaz approval represented an important step forward in bringing antibiotics for difficult-to-treat infections to market, allowing us to provide physicians with earlier access to Avycaz for their patients in need while continuing to explore the full benefit of the drug," David Nicholson, PhD, chief R&D officer at Allergan, said in the release. "These phase 3 data offer additional information about the efficacy of Avycaz in treating [cUTIs] caused by certain gram-negative pathogens and add to the complete body of clinical data."
Phase 3 results included in the current application demonstrated that ceftazidime-avibactam was noninferior to doripenem for both co-primary endpoints, including patient-reported symptomatic response at day 5 and the patient-reported symptomatic response and microbiological eradication at the test-of-cure visit, in the microbiologically modified intent-to–treat population. The overall results showed that cure rates were similar for patients with infections caused by cefazidime-nonsusceptible (CAZ-NS) pathogens and those with extended-spectrum beta-lactamase–producing pathogens. The data are supported by a second open-label phase 3 trial comparing ceftazidime-avibactam to the best available therapy in patients with cUTIs caused by CAZ-NS pathogens. The most common adverse events associated with Avycaz were diarrhea (8%), nausea (7%) and vomiting (5%) in patients with cIAIs, and constipation (10%) and anxiety (10%) in patients with cUTIs.
Allergan anticipates that the FDA will take action on the application’s filing in the first quarter of 2017.
Disclosure: Nicholson is an employee of Allergan.