EU/3/18/1992: Orphan designation for the treatment of myasthenia gravis

Efgartigimod alfa


On 21 March 2018, orphan designation (EU/3/18/1992) was granted by the European Commission to argenx BVBA, Belgium, for efgartigimod alfa (also known as ARGX-113) for the treatment of myasthenia gravis.

The sponsor's name and address was updated in September 2021.

The medicinal product has been authorised in the EU as Vyvgart since 10 August 2022.

Key facts

Active substance
Efgartigimod alfa
Intended use
Treatment of myasthenia gravis
Orphan designation status
EU designation number
Date of designation

Industriepark-Zwijnaarde 7
9052 Gent
Tel: +32 497 62 46 13

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

The Committee for Orphan Medicinal Products reviewed the orphan designation of Vyvgart 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

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:

Related content

How useful was this page?

Add your rating