Enalapril (1) – Aqumeldi®
Heart failure, < 18 years
Characteristics
| Start date | 01.03.2024 – Marketing authorisation: 15.11.2023 |
|---|---|
| Resolution | 15.08.2024 repealed |
| INN | Enalapril |
| Brand name | Aqumeldi® |
| Pharm. company | Proveca Pharma Limited |
| G-BA Procedure ID | D-1029 |
| ATC code | C09AA02 ACE inhibitors, plain (C09AA) |
| ICD-10 codes (AIS) | I50.00, I50.01, I50.11, I50.12, I50.13, I50.14, I50.19, I50.9Heart failure, unspecified |
| Alpha-ID codes (AIS) | I115729Left heart failure with symptoms at rest, I133762Secondary right heart failure, I15929Heart failure, I3867Left heart failure, I86836Primary right heart failure, I86842Left ventricular failure with symptoms during strenuous exercise, I86844Left heart failure, NYHA stage I, I86845Left heart failure with symptoms during light exercise |
| Therapeutic area | Cardiovascular diseases Chronic heart failure (CHF) |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Regulatory status | PUMA |
| Therapeutic indication of the resolution |
|---|
|
Aqumeldi is used to treat heart failure in children from birth to under 18 years of age. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Children and adolescents from 1 year to ≤ 17 years with heart failure | Captopril or sacubitril/valsartan |
| b) | Children from birth to < 1 year with heart failure | Captopril |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (WP08, WP09) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Bibliographic research) |
| Reason for dividing into subpopulations (G-BA) | Age |
- Clinical trials
- To assess the additional benefit of enalapril compared with the appropriate comparator therapy for the treatment of heart failure in children from birth up to and including 17 years of age, the pharmaceutical manufacturer has submitted the single-arm studies WP08, WP09 and the extension study WP10.
a) Children and adolescents aged 1 year and over up to ≤ 17 years with heart failure
- Captopril or sacubitril/valsartan was designated as the appropriate comparator therapy.
- An additional benefit is not proven.
- The single-arm studies submitted are not suitable for a benefit assessment due to the lack of comparison with the appropriate comparator therapy.
- Overall assessment
- In the overall assessment, the pharmaceutical manufacturer has therefore not provided any data that would allow a comparison of enalapril with the appropriate comparator therapy.
- An additional benefit of enalapril compared with the appropriate comparator therapy is therefore not proven.
b) Children from birth to < 1 year of age with heart failure
- Captopril was identified as the appropriate comparator therapy.
- An additional benefit is not proven.
- The single-arm studies submitted are not suitable for a benefit assessment due to the lack of comparison with the appropriate comparator therapy.
- Overall assessment
- In the overall review, the pharmaceutical manufacturer therefore does not provide any data that would allow a comparison of enalapril with the appropriate comparator therapy.
- An additional benefit of enalapril compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Enalapril (1) | Aqumeldi® | Proveca Pharma Limited | Heart failure, < 18 years |
0
3,070 |
100% additional benefit not proven repealed |
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