Vyvgart - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

efgartigimod alfa

Opinion

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Vyvgart. The marketing authorisation holder for this medicinal product is Argenx BV.

The CHMP adopted a new indication for Vyvgart solution for injection to include treatment of adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy, who previously received treatment with corticosteroids or immunoglobulins. The full indications for Vyvgart solution for injection will therefore be as follows:¹

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.

The indication for Vyvgart concentrate for solution for infusion remains unchanged and is provided in the summary of product characteristics (SmPC).

Detailed recommendations for the use of this product will be described in the updated SmPC, which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹ New text in bold

CHMP post-authorisation summary of positive opinion for Vyvgart (II-20)

AdoptedReference Number: EMA/CHMP/135941/2025

Key facts

• Name of medicine:
  Vyvgart
• EMA product number:
  EMEA/H/C/005849
• Active substance:
  Efgartigimod alfa
• International non-proprietary name (INN) or common name:
  efgartigimod alfa
• Therapeutic area (MeSH):
  Myasthenia Gravis
• Anatomical therapeutical chemical (ATC) code:
  L04AA58
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Argenx
• Date of opinion:
  25/04/2025
• Status:
  Positive