Ceftaroline fosamil for the treatment of acute bacterial skin and skin structure infections.
Skin infections have traditionally been classified by the US FDA as uncomplicated and complicated. In August 2010, the FDA released a new guidance document for the development of drugs to treat acute bacterial skin and skin structure infections (ABSSSI) and this was updated in 2013. Several new issues were addressed and henceforth skin infections in clinical trials were termed ABSSSI. In the USA, the annual prevalence of methicillin-resistant Staphylococcus aureus-related skin infections have continuously increased from 32.7% in 1998 to 53.8% in 2007. Ceftaroline fosamil is the only cephalosporin approved in the USA for monotherapy treatment of ABSSSI including infections caused by methicillin-resistant S. aureus. The efficacy of ceftaroline fosamil was shown in the CANVAS clinical trials. The CANVAS Day-3 analyses met an earlier, primary efficacy time point requested by the FDA. Ceftaroline has minimal drug-drug interactions, is well tolerated and possesses the safety profile associated with the cephalosporin class.
Global Medicines Development, Forest Research Institute, Harborside Financial Center, Plaza V, Jersey City, NJ 07311, USA.
Eric
E
Beresford
Donald
D
Biek
Alena
A
Jandourek
Yogesh
Y
Mawal
Todd
T
Riccobene
H David
HD
Friedland
D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D015195:Drug Design; D004347:Drug Interactions; D006801:Humans; D055624:Methicillin-Resistant Staphylococcus aureus / Q000302:isolation & purification; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D013203:Staphylococcal Infections / Q000188:drug therapy / Q000382:microbiology; D014481:United States; D014486:United States Food and Drug Administration; D000097583:Ceftaroline
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000097583:Ceftaroline