Allergan Plc Receives FDA Approval for AVYCAZ sNDA





Allergan plc a leading global pharmaceutical company, announced the U.S. FDA has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ® (ceftazidime and avibactam) with clinical data from a Phase 3 trial evaluating the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms.
 
The approved label also contains data from a subset of patients in this trial with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens, as well as a subset who had pathogens producing certain extended-spectrum beta-lactamases (ESBLs).
 
"Complicated intra-abdominal infections represent a major therapeutic challenge for physicians," said David Nicholson, Ph.D., Chief R&D Officer, Allergan. "AVYCAZ has been used in thousands of patients with these difficult-to-treat infections since it was first approved by the FDA in February 2015. The addition of these data to the label provides physicians with consistent evidence of the activity of AVYCAZ against some of the most challenging pathogens, including those for which we currently have limited treatment options."
 
"As a leader in anti-infectives, Allergan is committed to furthering the science needed to address the growing prevalence of these difficult-to-treat infections, helping physicians better understand the threat of challenging pathogens and equipping them with much needed treatments for their patients," Nicholson said.
 
This sNDA approval is based on results from a Phase 3 study that evaluated the efficacy and safety of AVYCAZ, in combination with metronidazole, for the treatment of patients with cIAI. The study showed that clinical cure rates at the Test of Cure (TOC) time point met the primary endpoint of statistical non-inferiority to meropenem. In a subset of patients with infections due to ceftazidime-resistant 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.   
 
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 over-express efflux pumps or have porin mutations.
 
AVYCAZ was first approved in the U.S. in February 2015 for the treatment of adult patients with cIAI, in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. In the treatment of cUTI, as only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients with cUTI who have limited or no alternative treatment options. Phase 3 studies evaluating the safety and efficacy of AVYCAZ for the treatment of cUTI have been completed, and the data is being analyzed for submission later this year.
 
About Allergan 
Allergan plc headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Allergan is focused on developing, manufacturing, and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines, and biologic products for patients around the world.
 
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, health care providers, and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.For more information, visit Allergan's website at www.allergan.com .
 
About AstraZeneca 
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
 
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