Allergan Announces FDA Approval Of TEFLARO For Pediatric Patients - Quick Facts

(RTTNews) - Allergan plc (AGN) said that the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application or sNDA for TEFLARO (ceftaroline fosamil), granting new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections or ABSSSI, including infections caused by methicillin-resistant Staphylococcus aureus or MRSA, and community-acquired bacterial pneumonia or CABP caused by Streptococcus pneumoniae and other designated susceptible bacteria.

These new indications were approved based on results from clinical studies evaluating TEFLARO in pediatric patients (2 months to less than 18 years of age), including one active-controlled study in ABSSSI and two active-controlled studies in CABP. In the ABSSSI active-controlled study, the efficacy and safety of TEFLARO was compared with vancomycin or cefazolin (each with optional aztreonam).

In the CABP studies, TEFLARO was compared with ceftriaxone. Use of TEFLARO in pediatric patients 2 months to less than 18 years of age is supported by evidence from adequate and well-controlled studies of TEFLARO in adults, as well as additional pharmacokinetic and safety data from pediatric trials.

The primary objective of the pediatric ABSSSI and CABP studies was to evaluate the safety and tolerability of TEFLARO. These studies were not powered for comparative inferential efficacy analysis, and no efficacy endpoints were identified as primary.

Results from the clinical studies in pediatric patients showed that TEFLARO demonstrated a safety profile that was compatible with treatment of ABSSSI and CABP at the clinical dosages studied. The safety findings were similar to those seen in the adult studies, and no safety concerns were identified beyond those already known to be cephalosporin class effects.