🇪🇺 IV efgartigimod in European Union

EMA authorised IV efgartigimod on 10 August 2022

Marketing authorisation

EMA — authorised 10 August 2022

  • Application: EMEA/H/C/005849
  • Marketing authorisation holder: Argenx
  • Local brand name: Vyvgart
  • Indication: Vyvgart is indicated as- an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.- monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.
  • Pathway: orphan
  • Status: approved

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Other Immunology approved in European Union

Frequently asked questions

Is IV efgartigimod approved in European Union?

Yes. EMA authorised it on 10 August 2022.

Who is the marketing authorisation holder for IV efgartigimod in European Union?

Argenx holds the EU marketing authorisation.