FDA Accepts Regulatory Review Filings for 2 of Merck's Antibacterial Agents
FEB 05, 2019 | MICHAELA FLEMING
The US Food and Drug Administration (FDA) has accepted for review 2 regulatory filings for antibacterial agents being developed by Merck.
A New Drug Application (NDA) was accepted for the Priority Review of the combination of relebactam with imipenem/cilastatin for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible gram-negative bacteria in adults with limited or no alternative therapies available.
A supplemental NDA (sNDA) was accepted for the Priority Review of ceftolozane/tazobactam (ZERBAXA) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by particular susceptible gram-negative microorganisms including Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
“There is a major unmet need for new treatment options to address the growing danger of serious and potentially life-threatening infections caused by Gram-negative bacteria,” Nicholas Kartsonis, MD, senior vice president and head of clinical research for infectious diseases and vaccines with Merck Research Laboratories, said in a statement.
In the United States, ceftolozane/tazobactam is currently approved for the treatment of adult patients with cUTI, including pyelonephritis, caused by particular gram-negative microorganisms, as well as in combination with metronidazole for the treatment of cIAI caused by susceptible gram-negative and gram-positive microorganisms in adult patients.
The NDA for imipenem/cilastatin/relebactam was based on the results of the phase 3 RESTORE-IMI1 trial. Relebactam is an investigational, intravenous, class A and C beta-lactamase inhibitor.
RESTORE-IMI 1 was a phase 3, randomized, active-comparator, controlled, double-blind study in which investigators set out to evaluate the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) compared with imipenem/cilastatin plus colistin (IMI+CST) in patients enrolled at multiple sites.
In a Poster Abstract Session at ID Week 2018 in San Francisco, California, Keith Kaye, MD, professor of medicine at the University of Michigan Medical School and Contagion® Editorial Advisory Board member, presented data on the RESTORE-IMI study which evaluated relebactam as a potential treatment option for treating carbapenem-resistant infections when used in combination with imipenem/cilastatin.
“One of the major findings, as well, is IMI/REL(imipenem/cilastatin/relebactam) had a significant advantage over (IMI+CST) in regard to toxicity, particularly acute kidney injury,” Dr. Kaye explained. “Colistin is notorious for its nephrotoxic effects and IMI/REL performed much better than IMI+CST (imipenem/cilastatin +colistin) in regards to nephrotoxicity.”
Merck also notes that the sNDA for ceftolozane/tazobactam were based on the phase 3 ASPECT-NP trial, which enrolled patients with ventilated hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia. The results of the phase 3 study will be announced at a future scientific conference, the company added.
The Prescription Drug User Fee Act (PDUFA) target action date for imipenem/cilastatin/relebactam is July 19, 2019, and the PDUFA date for ceftolozane/tazobactam is June 3, 2019.
Applications for both antibacterial agents have been filed with the European Medicines Agency (EMA) and are currently under review.
To stay informed on the latest in infectious disease news and developments, please sign upfor our weekly newsletter.
Contagion® is a fully integrated news resource covering all areas of infectious disease. Through our website, quarterly journal, email newsletters, social media outlets, and Outbreak Monitor we provide practitioners and specialists with disease-specific information designed to improve patient outcomes and assist with the identification, diagnosis, treatment, and prevention of infectious diseases. Our mission is to assure that the healthcare community and public have the knowledge to make more informed choices and have a positive impact on patient outcomes.
2 Clarke Drive
Cranbury, NJ 08512