Vyvgart
Neonatal Fc receptor (FcRn) blocker. Developed by argenx. Clinical, regulatory, and source evidence are connected below.
Latest signals
The three most recent source-backed changes linked to this drug.
N/A · NOT_YET_RECRUITING · BioSensics
Phase 2 · RECRUITING · Thomas Jefferson University
ARGENX BV · AP · SUPPL
Approved uses
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.
1 INDICATIONS AND USAGE VYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).
1 INDICATIONS AND USAGE VYVGART HYTRULO is indicated for the treatment of adult patients with: • generalized myasthenia gravis (gMG) • chronic inflammatory demyelinating polyneuropathy (CIDP)
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.
EMA's summary; the full indication is in the product information on the EPAR page.
Regulatory history
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.
Patents and exclusivity
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.
The Purple Book lists no licensed biosimilar.
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.
The current US labels have no boxed warning.
None on FDA's list names this drug.
Clinical trials
A focused view of recently updated studies · 8 linked records.
BioSensics · Updated Oct 13, 2026
Thomas Jefferson University · Updated Oct 6, 2026
M. Peter Marinkovich · Updated May 5, 2026
Chafic Karam · Updated Mar 12, 2026
Anastasia Vishnevetsky, MD, MPH · Updated Nov 10, 2025
Clinique Neuro-Outaouais · Updated Jul 29, 2025
Regulatory timeline
Verified regulatory records in reverse chronological order.
Related intelligence
Records connected through the current intelligence graph.
Source evidence
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.
