The supplemental New Drug Application (sNDA), which has been filed by the company and accepted by the regulator, is seeking approval for using Recarbrio for treating adult patients with HABP/VABP caused by certain susceptible Gram-negative microorganisms.
The Prescription Drug User Fee Act (PDUFA) date set for the sNDA by the FDA is 4 June 2020.
The sNDA is supported by the data of the phase 3 RESTORE-IMI 2 trial in adult patients having HABP/VABP.
In September 2019, Merck reported that the RESTORE-IMI 2 trial met its primary endpoint of statistical non-inferiority for Recarbrio compared to piperacillin/tazobactam in Day 28 all-cause mortality. The late-stage trial also met key secondary endpoints.
Merck Research Laboratories clinical research, infectious diseases and vaccines senior vice president Nicholas Kartsonis said: “This submission reinforces Merck’s continued dedication to researching and developing potential antibiotic treatment options which address unmet medical needs.
“We are unwavering in our commitment to evaluate treatments for infections caused by certain Gram-negative pathogens.”
In July 2019, Recarbrio was initially approved by the FDA for treating complicated urinary tract infections (cUTI). The infections for which the drug has been indicated under the approval include pyelonephritis, and complicated intra-abdominal infections (cIAI) resulting from susceptible Gram-negative bacteria, in adults who either have limited or do not have any alternative treatment options.
Recarbrio, which combines imipenem 500mg/cilastatin 500mg and relebactam 500mg, is intended to be intravenously administered.
Imipenem is a penem antibacterial drug, while cilastatin sodium is a renal dehydropeptidase inhibitor, which restricts the renal metabolism of the former and does not have antibacterial activity.
On the other hand, relebactam is a beta-lactamase inhibitor that had been granted the qualified infectious disease product (QIDP) designation and fast track status from the FDA for the treatment of HABP/VABP.
Last month, Merck completed its previously announced $2.7bn acquisition of US-based biopharmaceutical company ArQule, which is focused mainly on the research and development of targeted therapeutics for the treatment of cancers and rare diseases.