Published On: Mon, Jun 24th, 2013

FDA approves Vibativ for the treatment of bacterial pneumonia caused by Staphylococcus aureus

The U.S. Food and Drug Administration today expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable.

Credits:   CDC/Janice Carr

Credits: CDC/Janice Carr

Vibativ is approved only to treat S. aureus, not other bacteria that cause pneumonia.

“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,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

“Pneumonia is associated with one of the highest mortality rates among hospital-acquired infections and increases hospital stay and costs of care,” said Dr Ralph Corey, professor of medicine at the Duke University Medical Center and a principal investigator for Vibativ, PMLive reports.

“MRSA pneumonia, in particular, is an increasingly challenging infection as there are few approved treatments available today and resistance to current antibiotics remains a problem. Vibativ offers effectiveness in these difficult to treat infections when alternative therapies are not suitable.”

Bacterial pneumonia is a lung infection that can be caused by many different types of bacteria. HABP/VABP, also known as nosocomial pneumonia, is a particularly serious lung infection because patients in the hospital and especially those on ventilators are often already very sick and usually cannot fight the infection.

Vibativ’s safety and effectiveness to treat HABP/VABP were evaluated in 1,532 patients enrolled in two clinical trials. Patients were randomly assigned to receive Vibativ or vancomycin, another antibiotic approved by the FDA.

The trials measured the percentage of patients who died from any cause (all-cause mortality) 28 days after the initiation of treatment. Among patients presumed to test positive for S. aureus taken at baseline, mortality rates were comparable between the Vibativ and vancomycin treatment arms, except for patients who had pre-existing kidney problems.

During clinical trials, more patients with pre-existing kidney problems treated with Vibativ died compared to those treated with vancomycin. Vibativ can also cause new or worsening kidney problems in patients. This information has been added to Vibativ’s Boxed Warning.

Diarrhea was the most common side effect identified in the clinical trials.


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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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