FDA approves Merck/MSD’s antibiotic drug for bacterial pneumonia
Merck/MSD has won an approval from the FDA for its Gram-negative antibiotic Recarbrio, as a treatment for hospital-acquired and ventilator-associated bacterial pneumonia.
Recarbrio is a combination treatment comprised of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor.
Imipenem works to kill the bacteria associated with the infection while the other two active ingredients, cilastatin and relebactam, protect and increase imipenem’s effectiveness.
The new approval in hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) is based on results from the phase 3 RESTORE-IMI 2 trial, which compared Recarbrio to piperacillin/tazobactam (PIP/TAZ). Each drug was administered intravenously every six hours for seven to 14 days, among adult patients with HABP/VABP.
Merck/MSD’s drug met both the primary and secondary endpoints of the trial, demonstrating non-inferiority to (PIP/TAZ) in 28-day all-cause mortality and clinical response at early follow-up.
Recarbrio is also indicated for the treatment of adults who have limited treatment option for complicated urinary tract infections (cUTI) caused by susceptible Gram-negative bacteria.
According to Merck/MSD, Recarbrio should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, to reduce the development of drug-resistant bacteria and maintain the effectiveness of the drug and other antibacterials.
“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 healthcare practitioners in an effort to help them overcome the challenges in patient care,” said Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories.
Despite antibiotic resistance having been highlighted by the World Health Organisation (WHO) as ‘one of the biggest threats to global health, food security and development today’, few pharma companies are currently researching and developing new antibiotic drugs.
This is due to most effective drugs are used last, therefore there is little financial incentive to cover the cost of their development.