NEW YORK -- October 1, 2009 -- Health Canada has approved telavancin (Vibativ) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.
The approval is based on 2 large, multinational, double-blind, randomised phase 3 studies (ATLAS 1 and ATLAS 2) designed to compare the efficacy and safety of intravenous telavancin 10 mg/kg once daily versus intravenous vancomycin 1 gm every 12 hours in adult patients with cSSSI caused by Gram-positive bacteria.
A total of 1,867 patients were enrolled and treated, 719 of whom had infections with MRSA. In both of these studies, telavancin achieved its primary endpoint of non-inferiority relative to the standard of care, vancomycin.
The most common adverse reactions occurring in >= 10% of patients treated with telavancin were taste disturbance, nausea, vomiting, and foamy urine.
Serious adverse events were reported in 7% of patients treated with telavancin and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% of vancomycin-treated patients, and most commonly included cardiac, respiratory or infectious events.
SOURCE: Theravance, Inc.
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