Forest Laboratories announced that the FDA has approved Teflaro (ceftaroline fosamil), a cephalosporin, for the treatment of adults patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI) caused by susceptible strains of indicated pathogens. The approval for CABP was based on data from FOCUS I and FOCUS II clinical trials that evaluated the safety and efficacy of Teflaro compared to ceftriaxone-treated patients. Results showed that clinical cure rates were comparable for Teflaro and ceftriaxone: 86.6% and 82.3% for Teflaro and 78.2% and 77.1% in ceftriaxone in FOCUS I and FOCUS II, respectively.
The approval for ABSSSI was based on data from CANVAS I and CANVAS II clinical studies that evaluated the safety and efficacy of Teflaor compared to vancomycin plus aztreonam treated patients. Results showed that clinical cure rates were comparable for Teflaro and vancomycin/aztreonam: 91.1% and 92.2% for Teflaro and 93.3% and 92.1% in vancomycin/aztreonam in CANVAS I and CANVAS II, respectively.
Teflaro is expected to be available by January 2011.
For more information call (800) 678-1605 or visit www.frx.com.