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 Takeda GmbH
G-BA Procedure ID D-681
ATC code B06AC05 Drugs used in hereditary angioedema (B06AC)
DDD 21.4 mg P
Therapeutic area Other diseases Orphan (turnover limit)
Reason for procedure Reassessment: Orphan turnover exceeded
Original resolution: Lanadelumab (1) (01.08.2019)

Studies and Results

  • 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 Other diseases Hereditary angioedema, prophylaxis, 2 to < 12 years 1–30 100% additional benefit not proven Orphan (turnover limit)
Lanadelumab (2) Takhzyro® Takeda GmbH Other diseases 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 Other diseases Hereditary angioedema (HAE) 0
140–430 		100% considerable additional benefit Orphan repealed


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