Ceftaroline approved by FDA for treatment of MRSA skin infections
MedWire News: The injectable antibiotic ceftaroline fosamil has been approved by the US Food and Drug Administration (FDA) for treatment of acute bacterial skin and skin structure infections (ABSSSIs) including methicillin-resistant Staphylococcus aureus (MRSA).
The decision was based on the success of the previously published CANVAS (Comparative Study of Ceftaroline vs Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections) I and II studies, which included a total of 1396 participants.
An ABSSSI response rate of 74.0% versus 64.6% and 74.0% versus 68.1% was observed for ceftaroline versus combined treatment with vancomycin and aztreonam in the CANVAS I and II studies, respectively.
Ceftaroline was found to be generally well tolerated, with a safety profile consistent with the cephalosporin class of antibiotics. The FDA notes that patients with sensitivities to this class of antibiotics should not be prescribed ceftaroline. The most common side effects include diarrhea, nausea, and rash.
At the same time as being approved for treatment of ABSSSIs, ceftaroline was also approved for treatment of community acquired bacterial pneumonia (CABP) by the FDA.
This was also based on results from two clinical trials - FOCUS I and II - which included a total of 1231 patients with CABP who were treated with ceftaroline or ceftriaxone. The clinical cure rates achieved with ceftaroline versus ceftriaxone were 86.6% versus 78.2% and 82.3% versus 77.1% in the FOCUS I and II trials, respectively.
"These are serious and potentially life-threatening infections for which new treatment options are needed," said Edward Cox (FDA Center for Drug Evaluation and Research, Silver Spring, Maryland, USA). "The FDA is committed to facilitating new antibiotic drug development."
Dirk Thye from Forest Laboratories, Inc., which has developed ceftaroline, commented: "Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications."
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By Helen Albert