Berotralstat (1) – Orladeyo®
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
Characteristics
| Start date | 15.06.2021 – Marketing authorisation: 30.04.2021 |
|---|---|
| Resolution | 02.12.2021 |
| INN | Berotralstat |
| Brand name | Orladeyo® |
| Pharm. company | BioCryst Pharma Deutschland GmbH |
| G-BA Procedure ID | D-695 |
| ATC code | B06AC06 Drugs used in hereditary angioedema (B06AC) |
| ICD-10 codes (AIS) | D84.1C1 esterase inhibitor [C1-INH] deficiency |
| Alpha-ID codes (AIS) | I1966Hereditary angioedema |
| DDD | 0.15 g O |
| Therapeutic area | Other diseases Hereditary angioedema (HAE) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adolescents and adults aged 12 years and over with recurrent attacks of hereditary angioedema (HAE) | Routine prophylaxis with C1 esterase inhibitor |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
- Clinical trials
- No comparative data against the appropriate comparator therapy were provided for the assessment of the additional benefit of berotralstat for the long-term prevention of recurrent attacks of hereditary angioedema in adolescents and adults aged 12 years and over.
Adolescents and adults aged 12 years and over with recurrent attacks of hereditary angioedema
- For adolescents and adults aged 12 years and over with recurrent attacks of hereditary angioedema, the additional benefit of berotralstat compared with the appropriate comparator therapy is not proven.
- No comparative data against the appropriate comparator therapy were submitted for the assessment of the additional benefit of berotralstat for the long-term prophylaxis of recurrent attacks of hereditary angioedema in adolescents and adults aged 12 years and over. The additional benefit is therefore not proven.
- Overall assessment
- No comparative data against the appropriate comparator therapy were submitted. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Berotralstat (1) | Orladeyo® | BioCryst Pharma Deutschland GmbH | Hereditary angioedema (HAE), prophylaxis, ≥ 12 years | 140–430 | 100% additional benefit not proven |
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