Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted 21 – 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 – 0 in favor of approval for complicated skin and skin structure infections (cSSSI).
Ceftaroline is a novel, bactericidal, broad-spectrum injectable cephalosporin shown in pre-clinical and clinical trials to have activity against both gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common gram-negative pathogens.
The committee’s recommendation will be considered by the FDA as it reviews the new drug application (NDA) for ceftaroline, which was based primarily on data from two Phase III trials in CABP – FOCUS I and FOCUS II – and two Phase 3 trials in cSSSI – CANVAS I and CANVAS II. Forest anticipates action by the FDA during the fourth calendar quarter.
SOURCE Forest Laboratories