XYDALBA (dalbavancin) - Skin and soft tissue infections

The Committee deems that the clinical benefit of XYDALBA (dalbavancin) remains substantial for adult patients with ABSSTIs of a certain degree of severity, with an established or suspected staphylococcal cause and for which methicillin resistance has been established or is strongly suspected.

In view of:

• the new real-life data, showing off-label use,
• a simplification of the administration schedule in the light of its long half-life,
• its in vitro activity, efficacy and safety profile comparable to that of vancomycin in the marketing authorisation indications,
• the insufficient documentation of clinical efficacy and safety in severe and/or multi-resistant bacteria-induced skin infections.

the Committee deems that XYDALBA (dalbavancin) provides no clinical added value (CAV V) in relation to vancomycin in the treatment of ABSSTIs in adults with infections of a certain degree of severity, with an established or suspected staphylococcal cause and for which methicillin resistance has been established or is strongly suspected.