XYDALBA (dalbavancin) - Antibiotic

The Committee deems that the clinical benefit of XYDALBA (dalbavancin) 500 mg powder for concentrate for solution for infusion is substantial in the treatment of acute bacterial skin and skin structure infections (ABSSSI), only in patients aged from 3 months to 17 years with infections of a certain degree of seriousness, for whom a staphylococcal aetiology and methicillin resistance are demonstrated or strongly suspected.

Considering:

• simplification of the dosing regimen due to its long half-life,
• in vitro activity data, and pharmacokinetic/pharmacodynamic data enabling extrapolation of the efficacy and safety to paediatric patients in the MA indications,
• inadequate documentation of its clinical efficacy and safety in severe skin infections and/or those due to multi-drug resistant bacteria,

as in adults, the Committee deems that XYDALBA (dalbavancin) provides no clinical added value (CAV V) compared to vancomycin in the last-resort treatment of paediatric patients aged from 3 months to 17 years with ABSSSI of a certain degree of seriousness, for whom a staphylococcal aetiology and methicillin resistance are demonstrated or strongly suspected.

The Committee highlights the importance of consulting an antibiotic expert when making the therapeutic decision in view of persistent uncertainties in terms of resistance.