Vibativ Approval Adds Treatment Option for Serious Pneumonia
The FDA has approved the expanded use of Vibativ (telavancin; Astellas) 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.
The safety and efficacy to treat HABP/VABP were evaluated in two clinical trials. A total of 1,532 patients were randomized to receive Vibativ or vancomycin. The trial endpoint 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 Staphylococcus aureus taken at baseline, mortality rates were comparable between the Vibativ and vancomycin treatment arms, except for patients who had pre-existing kidney problems.
The boxed warning section now includes information about Vibativ causing new or worsening kidney problems in patients.
Vibativ, a lipoglycopeptide antibiotic, is also indicated in complicated skin and skin structure infections due to susceptible gram (+) bacteria.
For more information call (855) 633-8479 or visit Vibativ.com.