AbbVie’s Dalvance Approved for Pediatric Patients

FDA has approved AbbVie’s Dalvance (dalbavancin) for treating acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. The company says the therapy is the first single-dose option administered as a 30-minute intravenous infusion for treating ABSSSI caused by designated susceptible gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus.

Approval is based on data from a multicenter, open-label, actively controlled clinical trial. Data showed the proportion of patients with an early clinical response was 97.3% (73/75) in the Dalvance single-dose arm, 93.6% (73/78) in the Dalvance two-dose arm, and 86.7% (26/30) in the comparator arm, the company says.

Previously, the drug was approved for treating adult patients with ABSSSI caused by certain susceptible strains of Gram-positive microorganisms.