FDA OKs Telavancin for Patients With Bacterial Pneumonia

Mark Crane

June 21, 2013

The US Food and Drug Administration (FDA) today expanded the approved use of the antibiotic telavancin (Vibativ, Theravance, Inc) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus.

Telavancin, approved in 2009 to treat complicated skin and skin structure infections, should be used for the treatment of HABP/VABP only when alternative treatments are not suitable, the FDA said in a statement.

Bacterial pneumonia is a lung infection that can be caused by many different types of bacteria. Telavancin is approved treat only 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," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the statement.

Telavancin's safety and effectiveness to treat HABP/VABP were evaluated in 1532 patients enrolled in 2 clinical trials. Patients were randomly assigned to receive telavancin or vancomycin.

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 telavancin and vancomycin treatment arms, except for patients who had pre-existing kidney problems, according to the FDA.

During clinical trials, more patients with pre-existing kidney problems treated with telavancin died compared to those treated with vancomycin. Telavancin can also cause new or worsening kidney problems in patients. This information has been added to Vibativ's boxed warning, the FDA said.

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


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