The US Food and Drug Administration has approved a treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients 18 years of age and older. Merck created the antibiotic, called Recarbrio, which is a combination of imipenem-cilastatin and relebactam.
This drug was previously FDA approved to treat patients that have complicated urinary tract infections and complicated intra-abdominal infections that have had no alternative treatment options.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia occur in hospitalized patients. Symptoms can include fever, chills, cough, chest pain and increased oxygen requirements.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” said Dr. Sumathi Nambiar, director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”
The drug, Recarbrio, can only be administered intravenously by a health care professional. The safety and efficacy of the drug was evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
The most common reactions observed in patients that were treated with this drug included increased liver enzymes, anemia, diarrhea, hypokalemia and hyponatremia.
According to a statement, “this application was granted a Qualified Infectious Disease Program (QIDP) designation. This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. Additionally, as part of QIDP designation, the FDA granted this application Fast Track and Priority Review designations.”
Infectious Diseases and Vaccines senior vice president from Merck Research Laboratories, 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.”
HVAP and VABP are common hospital acquired pneumonia that can cause mortality or morbidity even after successful treatments and intensive care. These types of pneumonia can be contracted within 48 to 72 hours after being admitted to a hospital. This is even more pressing now with the rise of COVID-19. The virus COVID-19 is a respiratory disease that transfers from person to person. Patients that are COVID-19 positive and staying at hospitals put them at risk of acquiring HVAP and VABP. Therefore, solutions such as the antibiotic approved by the FDA, Recarbrio, could be one step closer into eliminating the deaths and risks to many individuals being admitted to hospitals.