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| |  FDA Approves Telavancin for Complicated Skin and Skin Structure Infections NEW YORK -- September 14, 2009 -- The US Food and Drug Administration (FDA) 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. "[Telavancin] has demonstrated its efficacy and safety in clinical trials for the treatment of Gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date," said principal investigator Ralph Corey, MD, Chapel Hill, North Carolina. "I believe [telavancin] will be a welcome addition for physicians treating this serious infection." Two multinational, double-blind, randomised phase 3 studies compared 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 studies, telavancin achieved its primary endpoint of non-inferiority relative to the standard of care, vancomycin. Telavancin has not been studied in children. The most common adverse reactions (10% of patients treated with telavancin) observed 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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