FDA approves new bacterial pneumonia antibiotic
HABP/VABP, also known as nosocomial pneumonia, is a very serious lung infection, affecting those with pre-existing respiratory problems. Bacterial pneumonia can be caused by many different bacterial infections. Vibativ is only approved to fight Staphylococcus aureus.
"Today's approval demonstrates the FDA's commitment to making available new therapeutic options to treat serious diseases like HABP/VABP, particularly for very ill patients who have exhausted or cannot take other available treatments," Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said.
Two clinical trials with 1,532 patients were used to test Vicativ's efficacy in comparison to vanvomycin, a current antibiotic approved to combat bacterial pneumonia. Subjects in the study were administered one of the antibiotics at random and researchers compared the data.
The data compared the mortality rates, which included all causes of death, amongst all patients 28 days after the initiation of treatment All data was comparable between the antibiotics for all patients likely to be infected with S. aureus. Patients with pre-existing kidney problems had a higher death rate with Vibativ compared to vancomycin.
The antibiotic was found to cause worsening of the kidneys and diarrhea.