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FDA Expands Label for Ceftaroline Fosamil (Teflaro)

Prescribing information includes new trial data

The FDA has approved a supplemental new drug application (sNDA) to update the label for ceftaroline fosamil (Teflaro, Allergan) for the treatment of adults with acute bacterial skin and skin-structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP).

The approved label includes new clinical data from two ABSSSI trials that involved patients with baseline Staphylococcus aureus bacteremia. With the updated label, ceftaroline fosamil is also approved to be administered by intravenous (IV) infusion in 5 to 60 minutes in adult patients (18 years of age and older).

The sNDA approval was based on a subset of data from two identical pivotal trials (CANVAS 1 and 2) that compared ABSSSI patients treated with ceftaroline fosamil monotherapy with patients treated with vancomycin plus aztreonam. Of the 693 patients in the modified intent-to-treat population in the ceftaroline fosamil arm in the two ABSSSI trials, 20 patients had baseline S. aureus bacteremia (nine cases of methicillin-resistant S. aureus [MRSA] and 11 cases of methicillin-susceptible S. aureus [MSSA]). Thirteen of these 20 patients (65%) achieved a clinical response with ceftaroline fosamil at day 3, and 18 of 20 patients (90%) were considered a clinical success at test of cure. These data are now included in the clinical trial section of the ceftaroline fosamil prescribing information.

Ceftaroline fosamil was first approved by the FDA in October 2010 for the treatment of adults with CABP and ABSSSI due to designated susceptible pathogens. Ceftaroline fosamil is a bactericidal cephalosporin with activity against both gram-positive and gram-negative pathogens. It is the first and only cephalosporin with activity against MRSA.

Ceftaroline fosamil is indicated for the treatment of ABSSSIs caused by susceptible bacterial isolates of the following gram-positive and gram-negative microorganisms: S. aureus (methicillin-susceptible and -resistant isolates) Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and K. oxytoca.

Ceftaroline fosamil is also indicated for the treatment of CABP caused by susceptible bacterial isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), S. aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K. pneumoniae, K. oxytoca, and E. coli.

To reduce the development of drug-resistant bacteria and to maintain the effectiveness of ceftaroline fosamil and other antibacterial drugs, ceftaroline fosamil should be used to treat only ABSSSI or CABP that is proven or strongly suspected to be caused by susceptible bacteria.

Source: Allergan; September 2, 2015.

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