Acoramidis (1) – Beyonttra®
Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
Characteristics
| Start date | 01.04.2025 – Marketing authorisation: 10.02.2025 |
|---|---|
| Resolution | 18.09.2025 |
| INN | Acoramidis |
| Brand name | Beyonttra® |
| Pharm. company | Bayer Vital GmbH |
| G-BA Procedure ID | D-1167 |
| ATC code | C01EB25 Other cardiac preparations (C01EB) |
| ICD-10 codes (AIS) | E85.0Non-neuropathic heredofamilial amyloidosis, E85.2Heredofamilial amyloidosis, unspecified, E85.4Localized amyloidosis, E85.8Other amyloidosis, E85.9Amyloidosis, unspecified |
| Alpha-ID codes (AIS) | I129348Hereditary transthyretin amyloidosis, I129352Wild-type transthyretin amyloidosis, I24316Amyloidosis, I2490Non-neuropathic heredofamilial amyloidosis, I66392Localized amyloidosis |
| Therapeutic area | Metabolic diseases HATTR- Amyloidosis |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Beyonttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM) | Tafamidis |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ATTRibute-CM) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
Adults with wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM)
- The additional benefit is not proven.
- No direct comparative study is available to assess the additional benefit of Acoramidis in comparison with the appropriate comparator therapy, Tafamidis.
- Overall, there are no suitable data available for assessing the additional benefit of Acoramidis compared with the appropriate comparator therapy, Tafamidis.
- In summary, it is concluded that, for adults with wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM), the additional benefit of Acoramidis over the appropriate comparator therapy, Tafamidis, is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Acoramidis (1) | Beyonttra® | Bayer Vital GmbH | Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy | 1,760–2,120 | 100% additional benefit not proven |
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