XYDALBA (dalbavancin), antibiotic of the glycopeptide class
INFECTIOUS DISEASES - New medicinal product
Opinions on drugs -
Posted on
Mar 29 2017
Reason for request
Inclusion
No clinical benefit demonstrated relative to vancomycin in the management of acute bacterial skin and soft tissue infections.
A role in non-serious infections of staphylococcal aetiology that are resistant to methicillin.
- XYDALBA has Marketing Authorisation in the treatment of acute bacterial skin and soft tissue infections in adults.
- It does not provide any clinical added value by comparison with vancomycin, since:
- its in-vitro activity profile, efficacy and safety are comparable to that of vancomycin;
- and there is insufficient documentation of clinical efficacy and safety in severe skin infections and/or skin infections caused by multidrug-resistant bacteria.
- It can be proposed only in situations where the use of a glycopeptide is formally indicated and only in adult patients with infections of a certain severity for which a staphylococcal aetiology and resistance to methicillin are proven or strongly suspected.
- Given the clinical data, the long half-life of the product and the uncertainties regarding its impact on safety (prolonged persistence of the product in case of adverse effect) and resistance, XYBALDA should be prescribed with the help of an antibiotic specialist consultant.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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