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

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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