Lanadelumab (2) – Takhzyro®
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
Characteristics
| Start date | 15.05.2021 – Marketing authorisation: 22.11.2018 |
|---|---|
| Resolution | 04.11.2021 |
| INN | Lanadelumab |
| Brand name | Takhzyro® |
| Pharm. company |
Dossier: Takeda GmbH
New distributor: TAKEDA GmbH |
| G-BA Procedure ID | D-681 |
| ATC code | B06AC05 Drugs used in hereditary angioedema (B06AC) |
| ICD-10 codes (AIS) | D84.1C1 esterase inhibitor [C1-INH] deficiency |
| Alpha-ID codes (AIS) | I1966Hereditary angioedema |
| ORPHAcodes (AIS) | 91378Hereditary angioedema |
| DDD | 21.4 mg P |
| Therapeutic area | Other diseases Hereditary angioedema (HAE) Orphan (turnover limit) |
| Reason for procedure |
Reassessment: Orphan turnover exceeded
Original resolution: Lanadelumab (1) (01.08.2019) |
| Therapeutic indication of the resolution |
|---|
|
Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Takhzyro is used in patients 12 years of age and older for routine prophylaxis of recurrent attacks of hereditary angioedema (HAE). | A routine prophylaxis with C1-esterase inhibitor |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + ITC (PID/PSM)) |
- Clinical trials
- The PATCH study is a retrospective comparison of individual patient data from three studies (the HELP RCT, the single-arm HELP-OLE extension study and the single-arm CHANGE-3 extension study).
- The prospective observational study by Hahn (2020) and a retrospective post-hoc analysis of the placebo-controlled RCT HELP were presented as before-and-after comparisons.
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 lanadelumab over the appropriate comparator therapy is not proven.
- Overall, based on the studies presented, no conclusions can be drawn regarding the additional benefit of lanadelumab compared with the appropriate comparator therapy. An additional benefit is therefore not proven.
- Overall assessment / Conclusion
- On the basis of the studies submitted, no conclusions can be drawn regarding the additional benefit of lanadelumab compared with the appropriate comparator therapy. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Lanadelumab (3) | Takhzyro® | Takeda GmbH | Hereditary angioedema, prophylaxis, 2 to < 12 years | 1–30 | 100% additional benefit not proven Orphan (turnover limit) | |
| Lanadelumab (2) | Takhzyro® | Takeda GmbH | Hereditary angioedema (HAE), prophylaxis, ≥ 12 years | 140–430 | 100% additional benefit not proven Orphan (turnover limit) | |
| Lanadelumab (1) | Takhzyro® | Shire Deutschland GmbH, Teil der Takeda Group | Hereditary angioedema (HAE) |
0
140–430 |
100% considerable additional benefit Orphan repealed |
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