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.
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