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Telavancin recommended as last resort for nosocomial pneumonia
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The FDA’s Anti-Infective Drugs Advisory Committee voted 9-6 against recommending telavancin for the treatment of nosocomial pneumonia.
However, the committee members voted 13-2 to recommend telavancin (Vibativ, Theravance) to treat nosocomial pneumonia, including ventilator-associated pneumonia, caused by methicillin-resistant and methicillin-sensitive Staphylococcus aureus, only when no other treatment alternatives are suitable. It is not recommended for Streptococcus pneumoniae.
Archana Chatterjee
“This is a deadly condition for which we have very few options, and this drug should be available to patients,” committee member Archana Chatterjee, MD, PhD, professor of pediatrics at Creighton University School of Medicine in Omaha, Neb., said at the meeting.
The particular concern was about the increased risk for mortality among patients with renal impairment and the drug’s effect on renal status.
“In the context of no other treatments being available, I’m willing to look at the data with a little more liberal eye,” committee member William Calhoun, MD, vice chair for research in the department of internal medicine at the University of Texas Medical Branch, said at the meeting.
Telavancin is currently indicated in the United States for complicated skin and skin structure infections. It is also approved for nosocomial pneumonia in the European Union, Norway and Iceland. Theravance previously filed a new drug application for this indication, but more data were required.
The recommendation is based on data from two phase 3, randomized, double blind studies that were designed to demonstrate the noninferiority of telavancin to vancomycin in the treatment of nosocomial pneumonia. The combined studies included 1,503 adult patients with nosocomial pneumonia. They were randomly assigned to IV telavancin 10 mg/kg every 24 hours or IV vancomycin 1 g every 12 hours. Telavancin was noninferior to vancomycin in patients with nosocomial pneumonia caused by gram-positive pathogens.
“There is an increased challenge in treating nosocomial pneumonia, particularly in the ICU setting, due to MRSA,” Marin Kollef, MD, professor of medicine of pulmonary and critical care at Washington University, said during the meeting. “These infections have a significant impact on morbidity, mortality and cost of care. Early, appropriate therapy is critical, but there are only two currently available therapies approved in the United States, vancomycin and linezolid, which are showing increased rates of resistance and reduced susceptibility. For these reasons, we need new and effective therapies to benefit our patients."