Bimekizumab (5) – Bimzelx®

Hidradenitis suppurativa (acne inversa))

Characteristics

Start date 01.06.2024 – Marketing authorisation: 19.04.2024
Resolution 22.11.2024
INN Bimekizumab
Brand name Bimzelx®
Pharm. company UCB Pharma GmbH
G-BA Procedure ID D-1060
ATC code L04AC21 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) L73.2Hidradenitis suppurativa
Alpha-ID codes (AIS) I6373Hidradenitis suppurativa
Therapeutic area Skin diseases Hidradenitis suppurativa (Acne inversa)
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Bimzelx is used to treat adult patients with active moderate to severe hidradenitis suppurativa (acne inversa) who have had an inadequate response to conventional systemic HS therapy.
Subpopulation Indication Comparator
Adults with active moderate to severe hidradenitis suppurativa (HS) who have had an inadequate response to conventional systemic HS therapy Adalimumab or secukinumab

Studies and Results

No. of studies
(best subpopulation) 		2 (BE HEARD I, BE HEARD) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)

  • Clinical trials
    • In the BE HEARD I and BE HEARD II registration trials, which were supplemented by the pharmaceutical manufacturer, a randomised comparison of bimekizumab versus placebo was conducted over 16 weeks.

Adults with active moderate to severe hidradenitis suppurativa (HS) who have an inadequate response to conventional systemic HS therapy

  • For adults with active moderate to severe hidradenitis suppurativa who respond inadequately to conventional systemic HS therapy, the additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.
  • The additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.
  • For adult patients with active moderate to severe hidradenitis suppurativa who have responded inadequately to conventional systemic HS therapy, no direct comparative studies of bimekizumab versus the appropriate comparator therapy are available.
  • Furthermore, no indirect comparison has been presented.
  • No conclusions regarding the additional benefit of bimekizumab compared with the appropriate comparator therapy can be drawn from these studies.
  • Overall, therefore, there are no data available that are suitable for a benefit assessment.
  • Overall assessment
    • On balance, the additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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