AbbVie's Dalvance For Bacterial Skin Infection Gets FDA Approval For Pediatric Patients

AbbVie's Dalvance For Bacterial Skin Infection Gets FDA Approval For Pediatric Patients
  • The FDA has approved AbbVie Inc's ABBV Dalvance (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. 
  • Dalvance is the first single-dose option administered as a 30-minute intravenous infusion for ABSSSI.
  • ABSSSI are bacterial infections of the skin and associated tissues primarily caused by Gram-positive pathogens. 
  • The approval is based on an analysis that evaluated an early clinical response at 48 to 72 hours based on achieving a more than 20% reduction in lesion size compared to baseline and no receipt of rescue antibacterial therapy for children three months and older. 
  • The proportion of patients with an early clinical response was 97.3% in the Dalvance arm and 86.7% in the comparator arm.
  • Price Action: ABBV shares are up 0.61% at $118.26 during the market session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar.
Posted In: BriefsSkin DisorderBiotechNewsHealth CareFDAGeneral