On 9 October 2015, orphan designation (EU/3/15/1551) was granted by the European Commission to Dyax Ltd, United Kingdom, for recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein for the treatment of hereditary angioedema.
This medicine is now known as lanadelumab.
The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland, in November 2017.
Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein has been authorised in the EU as Takhzyro since 22 November 2018.
The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch , Ireland in September 2021.
Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab)
Treatment of hereditary angioedema
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|October 2022||The sponsor's address was updated in October 2022.|
Documents related to this orphan designation evaluation
EU/3/15/1551: Public summary of opinion on orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein for the treatment of hereditary angioedema (PDF/126.83 KB)
First published: 16/11/2015
Last updated: 16/11/2015
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: