EU/3/15/1551: Orphan designation for the treatment of hereditary angioedema
Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab)
Table of contents
Overview
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.
Key facts
Active substance |
Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab)
|
Intended use |
Treatment of hereditary angioedema
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/15/1551
|
Date of designation |
09/10/2015
|
Sponsor |
Takeda Pharmaceuticals International AG Ireland Branch |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Takhzyro at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the
orphan medicine assessment report
Update history
Date | Update |
---|---|
October 2022 | The sponsor's address was updated in October 2022. |
Patients' organisations
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: