FDA Guidance

Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion sizes of>75 cm2 and excluded patients with ulcers or burns (updated all-treated population; n 1,127). Updated day 3 (early) clinical response was defined as a>20 % reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a>90 % reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6 % and 61.0 % of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95 % confidence interval [CI] of4.0 % to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95%CI,0.7 % to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin. Telavancin is an intravenous lipoglycopeptide antibacterialagent exhibiting concentration-dependent bactericidal effects againstmanyGram-positive cocci, includingmethicillin-resistant Staphylococcus aureus (MRSA), via a dual mechanism of action that combines inhibition of cell wall synthesis and disruption o