EU/3/15/1551: Orphan designation for the treatment of hereditary angioedema

Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab)

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
Block 2
Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
Tel: +1 800937970
E-mail: medinfoEMEA@takeda.com

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 PDF icon orphan medicine assessment report

Update history

Date Update
October 2022 The sponsor's address was updated in October 2022.

Documents related to this orphan designation evaluation

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:

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