FDA to Review Expanded Teflaro Indication in Pediatrics
Allergan announced that the Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Teflaro (ceftaroline fosamil). The sNDA is intended to expand its label to include children ≥2 months old for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant Staphylo
The sNDA submission was supported by data from 5 clinical studies evaluating Teflaro in pediatric patients, including 1 active-controlled study for ABSSSI, 2 active-controlled studies for CABP, and 2 pharmacokinetic (PK) studies. The efficacy and safety of Teflaro were compared with vancomycin or cefazolin with or without aztreonam in the ABSSSI study and with ceftriaxone or ceftriaxone plus vancomycin in the CABP studies.
Results from the ABSSSI trial showed that patients treated with Teflaro demonstrated an 80.4% clinical response, as measured by cessation of lesion spread and absence of fever, at Study Day 3 vs. 75% for the comparator group. In the CABP trials, clinical response, as measured by improvement in ≥2 out of 7 symptoms (cough, dyspnea, chest pain, sputum production, chills, feeling of warmth/feverish and exercise intolerance or lethargy) as well as no symptom worsening, at Study Day 4 was achieved in 69.2% of Teflaro-treated patients vs. 66.7% of the comparator group.
Teflaro is the first and only cephalosporin antibiotic with activity against MRSA. It is currently indicated for the treatment of adults with CABP and ABSSSI due to susceptible bacterial pathogens.
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