Merck announced Friday that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex
To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
“Hospital-acquired infections continue to be a significant cause of illness and death despite advances in our understanding of the contributing factors and prevention of these diseases,” said Dr. Keith Kaye, professor of medicine and director of research for the division of infectious diseases, University of Michigan Health System, and a principal investigator in the clinical program. “Because these infections are often caused by difficult to treat Gram-negative organisms, new therapeutic options such as RECARBRIO are urgently needed for patients.”
The additional indication in HABP/VABP is based on results of the pivotal Phase 3 RESTORE-IMI 2 trial that compared RECARBRIO 1.25 grams (imipenem 500 mg/cilastatin 500 mg/relebactam 250 mg) to piperacillin/tazobactam 4.5 grams (PIP/TAZ, piperacillin 4000 mg/tazobactam 500 mg), each administered intravenously every six hours for seven to 14 days, for the treatment of adult patients with HABP/VABP. RECARBRIO met the primary and key secondary endpoints, demonstrating non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up, respectively. The RESTORE-IMI 2 study abstract was published by the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).
“At a time of great public health concern about the need for new treatments to meet the evolving challenges posed by Gram-negative bacteria, we are proud to continue bringing new therapeutic options to health care practitioners in an effort to help them overcome the challenges in patient care,” said Dr. Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “Today’s approval is further affirmation of Merck’s steadfast commitment to meeting the needs of the health care community.”
RECARBRIO is also indicated in adults who have limited or no alternative treatment options for complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, as described below. RECARBRIO is administered via intravenous injection.