The Food and Drug Administration (FDA) has expanded the approval of Dalvance® (dalbavancin) to include treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms in pediatric patients. Previously, the treatment was only approved for adults 18 years of age and older.
Dalvance is a second-generation, semi-synthetic lipoglycopeptide. The approval was based on data from a multicenter, open-label, actively controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT02814916) that evaluated the efficacy and safety of dalbavancin in 183 patients from birth to less than 18 years of age with ABSSSI, along with 3 pharmacokinetic studies. Patients were randomly assigned 3:3:1 to receive dalbavancin as a single-dose or 2-doses intravenously (IV), or a comparator which included IV vancomycin (for methicillin-resistant Gram-positive infections), or IV oxacillin or flucloxacillin (for methicillin susceptible Gram-positive infections).
The primary objective was to evaluate the safety and tolerability of dalbavancin. A key secondary endpoint was early clinical response at 48 to 72 hours post-randomization based on at least a 20% reduction in lesion size compared with baseline and no receipt of rescue antibacterial therapy for children 3 months and older.
Findings demonstrated that the safety profile of dalbavancin in pediatric patients was similar to that observed in adult patients. The proportion of patients with an early clinical response was 97.3% (n=73/75) in the dalbavancin single-dose arm, 93.6% (n=73/78) in the dalbavancin 2-dose arm, and 86.7% (n=26/30) in the comparator arm.
Dalvance is supplied as a single-use vial containing 500mg of lyophilized powder for IV infusion after reconstitution and dilution. The recommended dosage for pediatric patients with a creatinine clearance of 30mL/min/1.73m2 and above is based on age and weight and is administered as a single dose.
Dalvance® (dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients. News release. AbbVie. July 23, 2021. Accessed July 26, 2021. https://www.prnewswire.com/news-releases/dalvance-dalbavancin-receives-fda-approval-to-treat-acute-bacterial-skin-and-skin-structure-infections-in-pediatric-patients-301340347.html.