ORBACTIV (oritavancin), antibiotic of the glycopeptide class
INFECTIOLOGY - NEW MEDICINAL PRODUCT
Opinions on drugs -
Posted on
Jan 18 2016
Reason for request
Inclusion
No clinical benefit demonstrated by comparison with vancomycin.
A role in non-serious infections of staphylococcal aetiology that are resistant to methicillin
- ORBACTIV has Marketing Authorisation in the treatment of acute bacterial infections of the skin and soft tissues in adults.
- It does not provide any therapeutic benefit 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 a glycopeptide is formally indicated and only in adult patients with infections of a certain severity for which a staphylococcal aetiology is proven or suspected and where resistance to methicillin is proven or strongly suspected.
- Given the characteristics of the product (long half-life) and current uncertainties about its clinical efficacy and safety in severe skin infections and/or skin infections caused by multidrug-resistant bacteria, the therapeutic decision must be made in consultation with an antibiotics expert.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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