Linzagolix (2) – Yselty®

• Clinical trials
  • The randomised controlled registration trials EDELWEISS 2 and EDELWEISS 3, in which linzagolix is compared with placebo in each case.

a) Adult female patients of childbearing age with endometriosis who have previously received medical or surgical treatment, for symptomatic management

• For women of childbearing age with endometriosis who have already received medical or surgical treatment, the additional benefit is not proven.
• Overall, therefore, for women of childbearing age with endometriosis who have already received medical or surgical treatment, the additional benefit of linzagolix compared with the appropriate comparator therapy is not proven.
• For women of childbearing age with endometriosis who have already received medical or surgical treatment, there are no direct comparative studies against the appropriate comparator therapy.
• Furthermore, during a literature search, the pharmaceutical manufacturer was unable to identify any suitable studies for an indirect comparison of linzagolix with the appropriate comparator therapy.
• Throughout the entire study phase, the use of any of the treatment options listed by the G-BA as the appropriate comparator therapy was not permitted. The studies are therefore not suitable for establishing any additional benefit of Linzagolix over the appropriate comparator therapy.
• Overall assessment
  • In summary, the additional benefit of linzagolix over the appropriate comparator therapy is not proven for women of childbearing age with endometriosis who have already undergone medical or surgical treatment.

Courtesy translation only, please refer to the German original.