Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Actavis has confirmed that the US Food and Drug Administration (FDA) has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI), including those caused by multi-drug resistant Gram-negative bacterial pathogens.
Subscribe to our email newsletter
As agreed with FDA, ceftazidime-avibactam was submitted as a 505(b)(2) NDA for the treatment of patients with cIAI and cUTI based on the efficacy and safety of ceftazidime, data from Phase II ceftazidime-avibactam studies, robust microbiology and PK/PD analyses. The FDA action date for ceftazidime-avibactam under the Prescription Drug User Fee Act (PDUFA) is expected during Q1 2015.
On August 19, 2014, Actavis announced positive topline results from the single pooled dataset of RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for ceftazidime-avibactam as a treatment for adult patients with cIAI. The company intends to submit the results of the Phase III studies to the FDA as a supplemental New Drug Application (sNDA).
"Today, there exists a serious and unmet need for new options to treat patients suffering from infections due to resistant Gram-negative pathogens, including Carbapenem Resistant Enterobacteriaceae (CRE)," said David Nicholson, Senior Vice President, Actavis Global Brands R&D.
"The acceptance of our filing for approval of ceftazidime-avibactam is a continuation of Actavis’ commitment to advancing anti-infective research and development, with a focus on enhancing patient care and outcomes for areas of greatest unmet medical need."
The FDA granted ceftazidime-avibactam Qualified Infectious Disease Product (QIDP) status for its indications of cIAI, cUTI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) on March 11, 2013. The QIDP designation provides certain incentives for the development of new antibiotics, including priority review, eligibility for the FDA’s fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
Ceftazidime-avibactam is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation, antipseudomonal cephalosporin, that is an established and respected treatment for serious Gram-negative bacterial infections, and avibactam, a next generation, non-ß lactam ß-lactamase inhibitor.
The addition of avibactam to ceftazidime protects ceftazidime from breakdown by ß-lactamases. ceftazidime-avibactam offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range of species of carbapenem-resistant Enterobacteriaceae (CRE) together with difficult to treat Pseudomonas aeruginosa combined with robust coverage of extended spectrum ß-lactamase (ESBL)-expressing pathogens.
Ceftazidime-avibactam is being jointly developed with Astra Zeneca. Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the rights to commercialize ceftazidime-avibactam in the rest of the world.