Linzagolix (2) – Yselty®
Endometriosis
Characteristics
| Start date | 15.12.2024 – Marketing authorisation: 22.11.2024 |
|---|---|
| Resolution | 05.06.2025 |
| INN | Linzagolix |
| Brand name | Yselty® |
| Pharm. company | Theramex Ireland Limited |
| G-BA Procedure ID | D-1147 |
| ATC code | H01CC04 Anti-gonadotropin-releasing hormones (H01CC) |
| ICD-10 codes (AIS) | N80.0Endometriosis of uterus, N80.1Endometriosis of ovary, N80.2Endometriosis of fallopian tube, N80.3Endometriosis of pelvic peritoneum, N80.4Endometriosis of rectovaginal septum and vagina, N80.5Endometriosis of intestine, N80.6Endometriosis in cutaneous scar, N80.8Endometriosis of thorax, N80.9Endometriosis, unspecified |
| Alpha-ID codes (AIS) | I133979Endometriosis of the uterus, I133980Endometriosis of the ovary, I133981Endometriosis of the intestine, I133982Endometriosis in skin scar, I23944Endometriosis, I6950Endometriosis genitalis, I7307Endometriosis of the uterine tube, I7311Endometriosis of the pelvic peritoneum, I7314Endometriosis of the rectovaginal septum |
| Therapeutic area | Genitourinary system diseases Endometriosis |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Yselty is used in adult women of childbearing age for the symptomatic treatment of endometriosis in women whose endometriosis has previously been treated medically or surgically |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients of childbearing age with endometriosis who have previously undergone medical or surgical treatment for symptomatic treatment | Individualised therapy under selection of – Dienogest – GnRH analogues (goserelin or buserelin or leuprorelin or triptorelin or nafarelin) – Relugolix/estradiol/norethisterone acetate – Surgical measures |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
- 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.
Associated procedures
| Linzagolix (2) | Yselty® | Theramex Ireland Limited | Endometriosis | 8,100–13,900 | 100% additional benefit not proven | |
| Linzagolix (1) | Yselty® | Theramex Ireland Limited | Uterine fibroid | 20,160–100,800 | 100% additional benefit not proven |
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