Linzagolix (1) – Yselty®
Uterine fibroid
Characteristics
| Start date | 15.09.2024 – Marketing authorisation: 14.06.2022 |
|---|---|
| Resolution | 06.03.2025 |
| INN | Linzagolix |
| Brand name | Yselty® |
| Pharm. company | Theramex Ireland Limited |
| G-BA Procedure ID | D-1098 |
| ATC code | H01CC04 Anti-gonadotropin-releasing hormones (H01CC) |
| ICD-10 codes (AIS) | D25.0Submucous leiomyoma of uterus, D25.1Interstitial leiomyoma of uterus, D25.2Subperitoneal leiomyoma of uterus, D25.9Leiomyoma of uterus, unspecified |
| Alpha-ID codes (AIS) | I1550Submucosal leiomyoma of the uterus, I1551Intramural leiomyoma of the uterus, I1552Subserous leiomyoma of the uterus, I21435Uterine myoma |
| Therapeutic area | Genitourinary system diseases Uterusmyoma |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Yselty is used in adult women of childbearing age to treat moderate to severe symptoms of uterine fibroids. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult women of childbearing age with moderate to severe symptoms of uterine fibroids | Individualised therapy under selection of: – symptom-oriented treatment: o Relugolix/estradiol/norethisterone acetate o Progestogens, taking into account the respective authorisation status (for patients for whom symptomatic treatment of prolonged and/or heavy menstruation (menorrhagia, hypermenorrhoea) is sufficient). – Invasive treatment options |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PRIMROSE 1, PRIMROSE 2) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| ACT change | 15.01.2025 – Rücknahme der Zulassung |
Adult women of childbearing age with moderate to severe symptoms of uterine fibroids
- For adult women of childbearing age with moderate to severe symptoms of uterine fibroids, the additional benefit is not proven.
- In summary, additional benefit is not proven for adult women of childbearing age with moderate to severe symptoms of uterine fibroids compared with the appropriate comparator therapy.
- Overall assessment
- On balance, therefore, the additional benefit of linzagolix over the appropriate comparator therapy is not proven for adult women of childbearing age with moderate to severe symptoms of uterine fibroids.
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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