FDA Approves Dalbavancin

This therapy becomes the first single-dose infusion to treat acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.

The Food and Drug Administration (FDA) has approved Dalvance (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.

“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,” Margaret Burroughs, MD, medical director, infectious diseases, AbbVie, said. "This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."

The therapy is produced by AbbVie, and is delivered as a 30-minute intravenous (IV) infusion for the treatment of ABSSSI caused by designated susceptible Gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

This approval is based on results from a multicenter, open-label, actively controlled clinical trial evaluating dalbavancin in pediatric patients from birth to less than 18 years of age with ABSSSI and 3 pharmacokinetic studies.

To evaluate the treatment effect of dalbavancin in the ABSSSI pediatric trial, an analysis was conducted on 183 patients with ABSSSI in the Modified Intent-to-Treat (mITT) population, which included all randomized patients who received any dose of study drug and had a diagnosis of ABSSSI caused by Gram-positive organism(s).

This analysis evaluated an early clinical response at 48 to 72 hours based on achieving a ≥ 20% reduction in lesion size compared to baseline and no receipt of rescue antibacterial therapy for children 3 months and older. The 5 patients in the age group birth to less than 3 months of age were not included in the efficacy analyses since they were enrolled with expanded inclusion criteria and only received the single-dose dalbavancin regimen.

The proportion of patients with an early clinical response was 97.3% (73/75) in the dalbavancin single-dose arm, 93.6% (73/78) in the dalbavancin 2-dose arm, and 86.7% (26/30) in the comparator arm.

The approved recommended dosage regimen of 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.