FDA expands approval to DALVANCE for Treatment of Acute Bacterial Skin Infections in kids
The U.S. 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.
Previously, the treatment was only approved for adults 18 years of age and older.
Dalvance is a second-generation, semi-synthetic lipoglycopeptide. The approval was based on data from a multicenter, open-label, actively controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT02814916) that evaluated the efficacy and safety of dalbavancin in 183 patients from birth to less than 18 years of age with ABSSSI, along with 3 pharmacokinetic studies. Patients were randomly assigned 3:3:1 to receive dalbavancin as a single-dose or 2-doses intravenously (IV), or a comparator which included IV vancomycin (for methicillin-resistant Gram-positive infections), or IV oxacillin or flucloxacillin (for methicillin susceptible Gram-positive infections).
DALVANCE is the first single-dose option administered 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).
"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," said Margaret Burroughs, medical director, infectious diseases, AbbVie. "This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."
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