EU/3/15/1551

About

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.

Key facts

Active substance
Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab)
Disease / condition
Treatment of hereditary angioedema
Date of first decision
09/10/2015
Outcome
Positive
EU designation number
EU/3/15/1551

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 iconorphan medicine assessment report

Sponsor's contact details

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
Tel. + 353 1 429 7700
E-mail: medinfoEMEA@shire.com

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;

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