There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point.
CANVAS=Ceftaroline vs Vancomycin in Skin and Skin Structure Infection. CANVAS 1=ABSSSI Trial 1, CANVAS 2=ABSSSI Trial 2.
Additional TOC Data from CANVAS Trials: |
90% (18/20) of TEFLARO patients with baseline S. aureus bacteremia demonstrated clinical success at TOC1 |
Monotherapy efficacy proven at TOC against the most common pathogens in ABSSSI1 | ||
Pooled clinical cure rates in ME patients, % (n/N) | ||
Pathogen | TEFLARO | Vancomycin + aztreonam |
Gram-positive | ||
MSSA | 93.0 (212/228) | 94.5 (225/238) |
MRSA | 93.4 (142/152) | 94.3 (115/122) |
S. pyogenes | 100.0 (56/56) | 96.6 (56/58) |
S. agalactiae | 95.5 (21/22) | 100.0 (18/18) |
Gram-negative | ||
E. coli | 95.2 (20/21) | 90.5 (19/21) |
K. pneumoniae | 94.4 (17/18) | 92.9 (13/14) |
K. oxytoca | 83.3 (10/12) | 100.0 (6/6) |
Monotherapy efficacy proven at TOC against the most common pathogens in ABSSSI1 | |
Pooled clinical cure rates in ME patients, % (n/N) | |
TEFLARO Monotherapy | Vancomycin + aztreonam |
Pathogen | |
Gram-positive | |
MSSA | |
93.0 (212/228) | 94.5 (225/238) |
MRSA | |
93.4 (142/152) | 94.3 (115/122) |
S. pyogenes | |
100.0 (56/56) | 96.6 (56/58) |
S. agalactiae | |
95.5 (21/22) | 100.0 (18/18) |
Gram-negative | |
E. coli | |
95.2 (20/21) | 90.5 (19/21) |
K. pneumoniae | |
94.4 (17/18) | 92.9 (13/14) |
K. oxytoca | |
83.3 (10/12) | 100.0 (6/6) |
MSSA=Methicillin-susceptible Staphylococcus aureus.
MRSA=Methicillin-resistant Staphylococcus aureus.
There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point.
These hypothetical case studies present examples of types of patients who may benefit from TEFLARO.
Please also see full Prescribing Information.
Please also see full Prescribing Information.