IV Antibiotic Approved for Kids With Skin Infections

Antibiotic dalbavancin (Dalvance), previously approved to treat bacterial skin infections in adults, received FDA approval for the pediatric population from birth, manufacturer AbbVie said in a press release on Friday.

Dalbavancin was described as the first single-dose option given as a 30-minute intravenous infusion to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by designated susceptible Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA) in pediatric patients.

The drug is given as a single dose in pediatric patients with creatinine clearance of 30 mL/min/1.73 m² and above based on a patient’s age and weight. Dalbavancin initially received FDA approval in adults in 2014.

AbbVie noted that ABSSSIs lead to 3 million pediatric healthcare visits per year, with cutaneous abscesses and cellulitis the most common types of skin infections. These types of bacterial infections are primarily caused by Gram-positive bacteria, such as S. aureus and Streptococcus pyogenes.

Approval was granted based on an open-label trial in 183 pediatric patients from birth to younger than age 18 years with an ABSSSI diagnosis. Patients were randomized 3:3:1 to receive a single dose of the drug, two doses of the drug, or a comparator antibiotic (IV vancomycin for methicillin-resistant Gram-positive infections or oxacillin or flucloxacillin for methicillin-susceptible Gram-positive infections).

The outcome was early clinical response in 48 to 72 hours, defined as achieving a more than 20% reduction in lesion size compared with baseline and not needing rescue antibacterial therapy if the patient was 3 months or older. Overall, 97.3% of patients achieved an early clinical response in the single-dose arm compared with 93.6% in the two-dose arm and 86.7% in the comparator arm.

AbbVie noted that anaphylactic and serious hypersensitivity reactions to dalbavancin have been reported, and to be cautious in patients with known hypersensitivity to glycopeptides. Patients should discontinue use following an allergic reaction. Infusion-related reactions, hepatic effects such as ALT elevations, and Clostridioides difficile-associated diarrhea were also reported. The most common adverse reaction in the pediatric population was pyrexia.