Forest Laboratories (Forest) has presented new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalised patients, at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.
The two pivotal trials demonstrated that ceftaroline administered intravenously met the primary endpoint of non-inferiority in patients with moderate-to-severe CAP requiring hospitalisation. Ceftaroline therapy was also generally well tolerated.
The randomized, double-blind, multicenter phase III studies compared clinical outcomes following treatment with ceftaroline versus ceftriaxone, in hospitalised adult patients with moderate-to -evere CAP.
The combined results of FOCUS 1 and FOCUS 2 demonstrated a clinical cure rate of 84.3% for ceftaroline and 77.7% for ceftriaxone in the integrated clinically evaluable (CE) patient population.
However, the overall microbiological response rate in the microbiologically evaluable (ME) population was 87% for ceftaroline and 81% for ceftriaxone. In the microbiological modified intent-to-treat (MITT) population, it was 84.8% for ceftaroline and 80.4% for ceftriaxone.
Dirk Thye, president of Cerexa, the wholly-owned anti-infectives subsidiary of Forest Laboratories, said: “The robust data that have emerged from FOCUS 1 and 2 demonstrate that ceftaroline is a very promising new cephalosporin for the treatment of serious pneumonia in hospitalised patients. The continuing medical need to deal with emerging resistance to existing therapeutic options is clear and urgent.
“These results, along with our prior positive results in complicated skin and skin structure infections (cSSSI)5, confirm that ceftaroline has unique properties allowing it to address this medical need. We intend to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cSSSI and CAP around the end of this calendar year.”