July 23, 2021
Dalvance® (dalbavancin – AbbVie) has received expanded U.S. FDA approval to treat acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms in patients of all ages. It was previously approved for use only in patients at least 18 years of age.
Acute infections of the skin and skin structures caused by bacteria affect an estimated 14 million people in the United States each year and are responsible for over 3 million emergency room visits. On average, hospitalization for ABSSSI lasts four days. Children with ABSSSI, which can be life-threatening, account for 3 million pediatric visits to doctors or emergency rooms annually.
In a clinical trial, 97.3% of pediatric patients (from newborns to less than 18 years of age) receiving a single dose of Dalvance had an early clinical response to treatment compared to 86.7% of patients receiving a current standard of care. Safety data was similar to that seen in adults receiving Dalvance.
Recommended dosing is based on individual patient factors, including age and creatinine clearance (a measure of kidney health). Dalvance is administered over the course of 30 minutes via intravenous infusion. Adults can receive either a single- or a two-dose regimen, with doses given one week apart for a two-dose regimen. Only a single-dose regimen is FDA approved for pediatric patients.
The FDA first approved Dalvance in 2014.