Dalbavancin has received US Food and Drug Administration (FDA) approval to treat acute bacterial skin and skin structure infections in pediatric patients.
AbbVie announced the US Food and Drug Administration has approved dalbavancin (Dalvance) for treatment of acute bacterial skin and skin structure infection (ABSSSI) in pediatric patients.1 It is the first single-dose treatment option administered as a 30-minute intravenous (IV) infusion for ABSSSI caused by susceptible Gram-positive bacteria in pediatric patients which includes infections caused by methicillin-resistant staphylococcus aureus (MRSA).
"Serious infections in children can be difficult to treat and the impact of ABSSSI among children is significant, as these infections often require IV antibiotics, resulting in hospitalization," said Margaret Burroughs, medical director, infectious diseases, AbbVie, Libertyville, Illinois. "This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."
This approval is based on results from a multicenter, open-label, actively controlled clinical trial (NCT02814916) evaluating dalbavancin as treatment in pediatric patients from 0 to 18 years diagnosed with ABSSI and 3 pharmacokinetic trials (NCT01946568, NCT02688790, and NCT00678106).
In NCT02814916, the safety and efficacy of dalbavancin was compared to vancomycin, intravenous oxacillin, and flucloxacillin. Patients were randomized 3:3:1 to be treated with single-dose dalbavancin, 2-dose dalbavancin, or comparator.
The primary endpoint of the study was to evaluate the safety and tolerability of dalbavancin. The trial was not powered for comparative inferential efficacy analysis. There was an analysis of 183 patients with ABSSI in a modified intent-to-treat (mITT) population, which included all randomized patients who received any dose of study drug and had a diagnosis of ABSSI by gram-positive organisms, to evaluate the treatment efficacy.
The analysis evaluated patient response at 48 to 72 hours on a 20% or greater reduction in lesion size compared to baseline and no past of rescue antibacterial therapy for pediatric patients 3 months and older. Of the 75 patients analyzed, 73 achieved an early clinical response (97.3%) in the single-dose arm, 73 out of 78 (93.6%) of the double-dose arm, and 26 of 30 (86.7%) patients in the comparator arm.
These results were similar to those observed in adults. The approved recommended dosage for dalbavancin in pediatric patients with a creatinine clearance of 30 mL/min/1.73m2 and above is a single-dose regimen based on the age and weight of the pediatric patient.
1. Dalvance® (Dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients | Abbvie news center. Accessed July 27, 2021. https://news.abbvie.com/news/press-releases/dalvance-dalbavancin-receives-fda-approval-to-treat-acute-bacterial-skin-and-skin-structure-infections-in-pediatric-patients.htm?view_id=5591