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.Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin, and relebactam) to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
The US FDA’s Center for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration/Wikipedia.org)
Subscribe to our email newsletter
The regulator has approved a supplemental new drug application (sNDA) for Recarbrio to treat patients 18 years of age and older with HABP/VABP caused due to susceptible Gram-negative microorganisms such as Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.
Imipenem is a carbapenem antibacterial, while cilastatin is a renal dehydropeptidase inhibitor, and the relebactam is a beta-lactamase inhibitor.
Relebactam safeguards imipenem from degradation by certain serine beta-lactamases such as SHV (Sulfhydryl Variable), TEM (Temoneira), CTX-M (Cefotaximase-Munich), P99 (Enterobacter cloacae P99), PDC (Pseudomonas-derived cephalosporinase), and KPC (Klebsiella-pneumoniae carbapenemase).
The additional indication for Recarbrio was based on data pivotal phase 3 RESTORE-IMI 2 study, which compared Recarbrio 1.25gms to piperacillin/tazobactam 4.5gms for the treatment of adult patients with HABP/VABP.
According to the company, Recarbrio achieved the primary and key secondary endpoints and showed non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up, respectively.
The RESTORE-IMI 2 is a phase 3, multinational, randomised, double-blind and non-inferiority study that randomised 535 hospitalised adults with HABP/VABP in 1:1 ratio to secure a dose of Recarbrio or PIP/TAZ in 113 trial sites.
Merck Research Laboratories clinical research, infectious diseases and vaccines senior vice president Dr Nicholas Kartsonis said: “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.
“Today’s approval is further affirmation of Merck’s steadfast commitment to meeting the needs of the health care community.”
In May, Merck agreed to acquire Themis Bioscience, an Austrian pharma company, which is currently engaged in developing a vaccine for Covid-19.
