Actavis plc confirmed that the U.S. 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.
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 2 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 Aug. 19, Actavis announced positive topline results from the single pooled dataset of RECLAIM-1 and -2, pivotal Phase 3 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 3 studies to the FDA as a supplemental New Drug Application (sNDA).
“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.
Date: September 5, 2014