Antibiotic Approved for Hospitalized Patients with Bacterial Pneumonia

It will aid "very ill patients who have exhausted or cannot take other available treatments," said Dr. Edward Cox, M.D., MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research.

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

Bacterial pneumonia is a lung infection that can be caused by many different types of bacteria. Vibativ is approved only to treat S. aureus, not other bacteria that cause pneumonia. HABP/VABP, 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," FDA's news release stated.

"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 Dr. Edward Cox, M.D., MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research.

FDA said Vibativ's safety and effectiveness were evaluated in 1,532 patients enrolled in two clinical trials. It was approved in 2009 to treat complicated skin and skin structure infections and is marketed by Theravance, Inc., based in San Francisco.

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    March 2021

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