VYVGART (Argenx Australia Pty Ltd)
Product name
VYVGART
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
119 (120 working days)
Active ingredients
efgartigimod alfa
Registration type
EOI
Indication
Vyvgart is indicated as
- an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine 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.