Allergan (AGN) Announces FDA Accepts sNDA for AVYCAZ

October 11, 2016 8:02 AM EDT

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Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam), seeking the addition of new Phase 3 clinical trial data evaluating AVYCAZ in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label. The FDA granted priority review status to this application based on the previous Qualified Infectious Disease Product (QIDP) designation for AVYCAZ and is expected to take action on the filing in the first quarter of 2017.

"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," said David Nicholson, Ph.D., Chief R&D Officer, Allergan. "These Phase 3 data offer additional information about the efficacy of AVYCAZ in treating complicated urinary tract infections caused by certain Gram-negative pathogens and add to the complete body of clinical data."

"We look forward to working with the FDA to add these data to the AVYCAZ label and are committed to the ongoing development of our anti-infectives portfolio to ensure physicians have both the access and confidence to use the tools needed to address serious infections," Nicholson said.

AVYCAZ was first approved in the U.S. in February 2015 for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. In June 2016, the FDA approved the addition of data from a Phase 3 cIAI clinical trial to the label that evaluated the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of cIAI including data from a subset of patients with infections caused by ceftazidime-nonsusceptible (CAZ-NS) pathogens and a subset of patients with pathogens producing certain extended-spectrum beta-lactamases (ESBLs).

The application included results from a Phase 3 study evaluating the efficacy and safety of AVYCAZ for the treatment of patients with cUTI, including pyelonephritis. In this study, AVYCAZ demonstrated non-inferiority to doripenem with regard to both co-primary endpoints (patient-reported symptomatic response at Day 5 and the combined patient-reported symptomatic response and microbiological eradication at the Test of Cure [TOC] visit) in the microbiologically modified intent-to treat (mMITT) population. In a subset of patients with cUTI due to CAZ-NS pathogens, as well as a subset who had pathogens that produced certain ESBLs, clinical cure rates for patients treated with AVYCAZ were similar to the overall results. The application also included data from a second open-label Phase 3 study comparing AVYCAZ to best available therapy for treating patients with cUTI due to CAZ-NS pathogens. The results of this study were consistent with the pivotal Phase 3 study evaluating the efficacy and safety of AVYCAZ for the treatment of patients with cUTI.

AVYCAZ has demonstrated in vitro activity against Enterobacteriaceae in the presence of some beta-lactamases and ESBLs of the following groups: TEM, SHV, CTX-M, Klebsiella pneumoniae carbapenemase (KPCs), AmpC and certain oxacillinases (OXA). AVYCAZ also demonstrated in vitro activity against Pseudomonas aeruginosa in the presence of some AmpC beta-lactamases, and certain strains lacking outer membrane porin (OprD). AVYCAZ is not active against bacteria that produce metallo-beta lactamases and may not have activity against Gram-negative bacteria that overexpress efflux pumps or have porin mutations.

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