08 Jun VP Cartu Jonathan Announced – FDA approves new drug to treat hospital-acquired pneumonia
The FDA has approved a new drug called Recarbrio to treat hospital acquired pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Recarbrio has previously been used to treat patients with urinary tract complications and is a last resort for intraabdominal infections.
Recarbrio is a combination of imipenem-cilastatin and relebactam and is administered intravenously in patients 18 years of age or older.
The safety of this drug was determined through randomized, clinical trials in which 535 adults with HABP/VABP were given two treatments. One group consisting of 266 patients received Recarbrio and the remaining 269 adults were given another antibacterial drug known as piperacillin-tazobactam. By the end of the 28-day study, 21-percent of patients who had received piperacillin-tazobactam died, while only 16-percent of patients who received the Recarbrio died.
When treating with Recarbrio, some of the most common adverse reactions observed included increased liver enzymes (aspartate/alanine aminotransferases), diarrhea, and anemia. The FDA also cautions this drug not be used on patients who suffer from seizures and other central nervous system disorders.
In addition to the FDA approval, Recarbrio was also designated as a Qualified Infectious Disease Program (QDIP), which is a title given to antibacterial or antifungal drug products used to treat life-threatening infections.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” Sumathi Nambiar, M.D., M.P.H., director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research, said in a press release. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”