Ixekizumab (6) – Taltz®

Enthesitis-associated arthritis, ≥ 6 years

Characteristics

Start date 01.10.2025 – Marketing authorisation: 22.08.2025
Resolution 19.03.2026
INN Ixekizumab
Brand name Taltz®
Pharm. company Lilly Deutschland GmbH
G-BA Procedure ID D-1252
ATC code L04AC13 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) M08.89Other juvenile arthritis, multiple sites
Alpha-ID codes (AIS) I120123Enthesitis-associated arthritis
Therapeutic area Musculoskeletal system diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Taltz, either on its own or in combination with methotrexate, is indicated for the treatment of active EAA in patients aged 6 years and over and weighing at least 25 kg who have previously responded inadequately to, or are intolerant of, conventional therapy.
Subpopulation Indication Comparator
Kinder und Jugendliche ab 6 Jahren mit aktiver Enthesitis-assoziierter Arthritis und einem Körpergewicht von mindestens 25 kg, die unzureichend auf eine konventionelle Therapie angesprochen haben oder diese nicht vertragen

Studies and Results

  • Clinical trials
    • The COSPIRIT-JIA trial, on which the marketing authorisation is based, was an open-label, randomised trial comparing ixekizumab with adalimumab.

Children and adolescents aged 6 years and over with active enthesitis-related arthritis and a body weight of at least 25 kg who have responded inadequately to, or are unable to tolerate, conventional therapy

  • The additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data to assess the additional benefit of ixekizumab compared with the appropriate comparator therapy.
  • In accordance with the pharmaceutical manufacturer’s approach set out in the dossier, no suitable studies could be identified for the benefit assessment of ixekizumab.

Courtesy translation only, please refer to the German original.

Associated procedures



<< List of all resolutions