ZINPLAVA (bezlotoxumab), anti-toxin B monoclonal antibody of Clostridium difficile

INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Sep 07 2017

Reason for request

Inclusion

Minor improvement in the prevention of recurrent Clostridium difficile infection in adults at high risk for recurrences

  

  • ZINPLAVA has Marketing Authorisation in the prevention of recurrent Clostridium difficile infection (CDI) in adults at high risk for recurrent CDI.
  • Its efficacy has been demonstrated in combination with metronidazole and vancomycin.
  • There is no robust efficacy data, in combination with fidaxomicin, or in more severe forms and/or with multiple recurrent infections (history of more than one episode of CDI). Its safety profile is overall satisfactory, with a reservation about use in patients with underlying congestive heart failure.

 

»  The therapeutic decision must be made with the assistance of an antibiotics specialist.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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