FDA approves Dalvance for pediatric ABSSSI treatment
The FDA approved the AbbVie’s Dalvance (dalbavancin) for the treatment of acute bacterial skin and skin structure infections in pediatric patients from birth, according to a press release.
Dalvance is the first single-dose option administered as a 30-minute intravenous infusion for the treatment of ABSSSI caused by designated susceptible Gram-positive bacteria in pediatric patients, including infections from MRSA, the company said.
The approval was based on results from a multi-center, open-label, actively controlled clinical trial evaluating Dalvance in pediatric patients from birth to less than 18 years of age with ABSSSI and three pharmacokinetic studies.
"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, AbbVie medical director, infectious diseases. "This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."