Recently, AbbVie announced that the FDA approved Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients (from birth to under 18). This is the first and only single-dose infusion regimen for the treatment of ABSSSI in pediatric patients from birth. In May 2014, Dalbavancin was approved by the FDA for the treatment of ABSSSI in adults (18 years and older). This approval expands the population of dalbavancin used in ABSSSI.

ABSSSI is a bacterial infection of the skin and related tissues, mainly caused by Gram-positive bacteria, including Staphylococcus aureus (methicillin-sensitive strains and resistant strains, etc.) and Streptococcus pyogenes. Patients will have systemic symptoms such as swollen lymph nodes or fever. ABSSSI is an important source of childhood morbidity and can be life-threatening in severe cases. Skin abscesses and cellulitis are the main types of skin infections assessed by pediatricians.

Dalbavancin is a second-generation semi-synthetic lipoglycopeptide antibiotic that inhibits the synthesis of bacterial cell walls. It has bactericidal activity against a series of Gram-positive bacteria in vitro, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA strains) and Streptococcus pyogenes, as well as certain other Streptococcus species.

The FDA's approval is based on the results of a multi-center, open-label, positive-controlled clinical trial and 3 pharmacokinetic studies to evaluate the safety and effectiveness of dalbavancin in pediatric patients. In the study, patients were randomly assigned at a ratio of 3:3:1 and received single-dose dalbavancin, double-dose dalbavancin, and control antibiotic regimens.

To evaluate the therapeutic effect of dalbavancin, 183 patients with ABSSSI in the modified intention-to-treat (mITT) population were analyzed. The analysis results showed that the proportion of patients with early clinical response was 97.3% (73/75) in the dalbavancin single-dose group, 93.6% (73/78) in the double-dose group, and 86.7% (26) in the control group. /30). In addition, the safety results of dalbavancin in pediatric patients are similar to those observed in adult patients.

At present, a total of 7 new drugs for the treatment of ABSSSI have been approved for marketing worldwide, one is in the application for listing stage, and one is in the phase III clinical stage.