Angelini Pharma receives positive CHMP opinion for Xydalba®

AP22 1030 Xydalba
  • Published: 2 Nov 2022

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval to the extension of the existing indication of Xydalba (dalbavancin) to include the pediatric population (patients aged 3 months and older) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

ABSSSI are a group of bacterial skin infections, with severity ranging from mild infections to life‑threatening disease. The label extension for dalbavancin to include the treatment of ABSSSI in children, starting from three months of age, was based on interim results from a multicenter, open-label, actively controlled Phase 3 study, evaluating dalbavancin’s efficacy and safety in pediatric patients from birth to less than 18 years of age with ABSSSI.

Infectious diseases remain a major cause of concern worldwide, so this recommendation is an important advancement in the treatment of children with skin infections.