Evinacumab (2) – Evkeeza®
Homozygous familial hypercholesterolemia, ≥ 5 to < 12 years of age
Characteristics
| Start date | 15.01.2024 – Marketing authorisation: 11.12.2023 |
|---|---|
| Resolution | 04.07.2024 |
| INN | Evinacumab |
| Brand name | Evkeeza® |
| Pharm. company | Ultragenyx Germany GmbH |
| G-BA Procedure ID | D-1028 |
| ATC code | C10AX17 Other lipid modifying agents (C10AX) |
| Therapeutic area | Metabolic diseases |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Exceptional Circumstances |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- The pharmaceutical manufacturer has submitted the single-arm trial R1500-CL-17100 for the benefit assessment of evinacumab.
Children and adolescents aged 5 to < 12 years with homozygous familial hypercholesterolaemia, in whom dietary and pharmacological options for lowering lipid levels have been exhausted
- The additional benefit is not proven.
- To assess the additional benefit of evinacumab for the treatment of children and adolescents aged 5 to < 12 years with homozygous familial hypercholesterolaemia, in whom dietary and pharmacological options for lowering lipids have been exhausted, the pharmaceutical manufacturer cites the single-arm study R1500-CL-17100.
- Due to the lack of a comparator, the single-arm study R1500-CL-17100 is not suitable for drawing conclusions regarding the additional benefit of evinacumab compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Evinacumab (1) | Evkeeza® | Ultragenyx Germany GmbH | Homozygous familial hypercholesterolemia, ≥ 12 years of age | 73–80 | 100% additional benefit not proven | |
| Evinacumab (2) | Evkeeza® | Ultragenyx Germany GmbH | Homozygous familial hypercholesterolemia, ≥ 5 to < 12 years of age | 5–6 | 100% additional benefit not proven |
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