ZINBRYTA (daclizumab), immunosuppressant

NEUROLOGY - New medicinal product
Opinions on drugs - Posted on Mar 13 2017

Reason for request

Inclusion

No clinical benefit demonstrated in the treatment of relapsing forms of multiple sclerosis.

   

  • ZINBRYTA, administered subcutaneously, has Marketing Authorisation in relapsing forms of multiple sclerosis (MS) in adults. This indication includes relapsing/remitting (RR) MS, relapsing secondary progressive (SP) MS and patients who presented a single demyelinising event.
  • It is a therapeutic alternative usable in first or second-line treatment in all relapsing forms of MS.
  • Its superiority has been demonstrated relative to a first-line treatment (interferon β1a AVONEX) in terms of annualised relapse rates to the detriment of a less-favourable safety profile, particularly with serious adverse events.
  • The absence of direct comparison with treatments indicated in highly active forms of RRMS does not allow its contribution in these patients to be quantified.
  • However, there are no data documenting its efficacy or safety in patients with relapsing SPMS.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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