Reason for request

Extension of indication

Insufficient actual benefit in the treatment of invasive candidiasis in adults with neutropenia

  

  • ECALTA now has Marketing Authorisation in the curative treatment of invasive candidiasis in adults with neutropenia.
  • Given the low level of proof, with respect to the alternatives and the absence of comparative study versus another echinocandin or liposomal amphotericin B, ECALTA has no role in the therapeutic strategy in invasive candidiasis in adults with neutropenia.
  • Its benefit as an alternative to other echinocandins (caspofungin or even micafungin) has not been established in this indication.

 


Clinical Benefit

Substantial

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Insufficient

Clinical Added Value

Not applicable

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Therapeutic use

-

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