Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.
The approved prescribing information of ceftaroline states that it is indicated for:
– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.
– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.
In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).
Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.
At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.
Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.