FDA Expands Teflaro Use in Pediatric Patients
Allergan announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Teflaro (ceftaroline fosamil) for new indications in patients aged 2 months to <18 years old with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcal pneumoniae and other designated susceptible bacteria.
The FDA approval of the new indications were based on data from clinical studies evaluating Teflaro in pediatric patients, including 1 active-controlled study in ABSSSI and 2 active-controlled studies in CABP. In the ABSSSI active-controlled study, the safety and efficacy of Teflaro was compared with vancomcyin or cefazolin (with optional aztreonam). The CABP studies compared Teflaro with ceftriaxone. The use of Teflaro in patients aged 2 months to <18 years is supported by data from adequate and well-controlled studies of Teflaro in adults, in addition to pharmacokinetic and safety data from pediatric trials.
The treatment effect of Teflaro in the ABSSSI pediatric trial was evaluated in an analysis of 159 patients with ABSSSI in the modified intent-to-treat (MITT) population. Patients in the Teflaro treatment group showed a higher response at Study Day 3 vs. the comparator group, with clinical response achieved in 80.4% of patients vs. 75%, respectively (treatment difference 5.4%, 95% CI: -7.8, 20.3).
The treatment effect of Teflaro in the CABP trial was evaluated in 143 patients with CABP in the MITT population. At Study Day 4, the clinical response was 69.2% in the Teflaro treatment group vs. 66.7% in the comparator group (treatment difference 2.5%, 95% CI: -13.9, 20.9).
Teflaro is the first cephalosporin antibiotic indicated in adults and pediatric patients for the treatment of ABSSSI and CABP due to designated susceptible pathogens. It can be infused intravenously in 5 minutes to 1 hour. It is available as 400mg and 600mg strength vials in 1- and 10-count packages.
For more information call (800) 433-8871 or visit Teflaro.com.