Vyvgart (efgartigimod alfa)
- Region
- 🇪🇺 EU
- Active substance
- efgartigimod alfa
- Company
- Argenx
- Status
- Authorised
- Therapeutic area
- Myasthenia Gravis; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- CHMP opinion
- Thu 23 Jun 2022
- EU approval
- Wed 10 Aug 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005849
- ATC
- L04AA58
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
Vyvgart (efgartigimod alfa): DHPC sent to healthcare professionals
Quality defect; Myasthenia Gravis, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.