EU/3/18/1992: Orphan designation for the treatment of myasthenia gravis
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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.
Treatment of myasthenia gravis
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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 orphan medicine assessment report
Documents related to this orphan designation evaluation
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: