dalbavancin (Xydalba)

following a full submission

dalbavancin (Xydalba®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

SMC restriction:

• for second-line use or when meticillin-resistant Staphylococcus aureus (MRSA) infection is suspected, or on the advice of local microbiologists or specialists in infectious disease, and
• the patient is initially hospitalised due to ABSSSI, requires intravenous antibiotics, but is eligible for early discharge as soon as their medical condition does not require further inpatient treatment.

In two phase III double-blind studies of patients with ABSSSI, dalbavancin was non-inferior to the comparator for clinical response at end of treatment in the clinically evaluable population.