Linzagolix (endometriosis); Benefit assessment according to §35a SGB V

18.03.2025 Linzagolix for endometriosis: comparative data are lacking For endometriosis, there are no comparative studies with established drugs. Placebo comparisons are unsuitable for assessing the added benefit. Press release Last updated 17.03.2025 Project no.: A24-123 Commission: Commission awarded on 16.12.2024 by the Federal Joint Committee (G-BA). Report type: Dossier assessment Status: Commission completed Department/Division: Drug Assessment Topic: Reproductive health and birth Indication: Symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis; with concomitant hormonal add-back therapy Result of dossier assessment: Added benefit not proven Note: After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website. DOI: https://doi.org/10.60584/A24-123_en 18.03.2025 For endometriosis, there are no comparative studies with established drugs. Placebo comparisons are unsuitable for assessing the added benefit. Press release - Extract of dossier assessment: Linzagolix (endometriosis) – Benefit assessment according to §35a Social Code Book V DOI: https://doi.org/10.60584/A24-123_en EN, PDF, 244 kB, PDFpublished on Mar 17, 2025 - Dossier assessment: Linzagolix (endometriosis) – Benefit assessment according to §35a Social Code Book V DOI: https://doi.org/10.60584/A24-123 DE, PDF, 423 kB, PDFpublished on Mar 17, 2025 | Project no. | Title | Status | |---|---|---| | A24-92 | Linzagolix (uterine fibroids) – Benefit assessment according to §35a Social Code Book V | Commission completed |