Transient neonatal myasthenia gravis

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At a Glance

Live from database

Regulatory Watchboard

7 events
Jan 2026ZILBRYSQ: New indication approved
FDAcompleted
Apr 2025Imaavy: FDA approved

treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

FDAcompleted
Oct 2023Zilbrysq: FDA approved

Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

FDAcompleted
Jun 2023Rystiggo: FDA approved

treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

FDAcompleted
Jun 2023Vyvgart Hytrulo: FDA approved

treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

FDAcompleted
Dec 2021Vyvgart: FDA approved

treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

FDAcompleted
Oct 2017

SOLIRIS: FDA approved

for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

FDAcompleted

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

5 programs

FINANCIAL LANDSCAPE SUMMARY

5

Total programs

5

Open now

Patient Assistance Programs5

BKEMV

Amgen Inc

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Uplizna

Horizon Therapeutics USA, Inc.

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Imaavy

Janssen Biotech, Inc.

OpenContact for details

Zilbrysq

UCB, Inc.

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Rystiggo

UCB, Inc.

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Approved Treatments

8 FDA-approved

Imaavy

(NIPOCALIMAB)Orphan drug

Janssen Biotech, Inc.

12.1 Mechanism of Action Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of...

Approved Apr 2025FDA label ↗

Zilbrysq

(ZILUCOPLAN)Orphan drug

UCB, Inc.

Complement Inhibitor [EPC]

12.1 Mechanism of Action Zilucoplan binds to the complement protein C5 and inhibits its cleavage to C5a and C5b, preventing the generation of the term...

Approved Oct 2023FDA label ↗

Rystiggo

(ROZANOLIXIZUMAB)Orphan drug

UCB, Inc.

Neonatal Fc Receptor Blocker [EPC]

12.1 Mechanism of Action Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the ...

Approved Jun 2023FDA label ↗

Vyvgart Hytrulo

(EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT))Orphan drug

argenx US

Neonatal Fc Receptor Blocker [EPC]

12.1 Mechanism of Action VYVGART HYTRULO is a coformulation of efgartigimod alfa and hyaluronidase. Efgartigimod alfa is a human IgG1 antibody fragmen...

Approved Jun 2023FDA label ↗

Vyvgart

(EFGARTIGIMOD ALFA)Orphan drug

argenx US

Neonatal Fc Receptor Blocker [EPC]

12.1 Mechanism of Action Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the redu...

Approved Dec 2021FDA label ↗

SOLIRIS

(ECULIZUMAB)Orphan drug

Alexion Pharmaceuticals Inc.

Approved Oct 2017FDA label ↗

BKEMV

(ECULIZUMAB-AEEB)Orphan drugstandard

Amgen Inc

FDA label ↗

Uplizna

(INEBILIZUMAB)Orphan drugstandard

Horizon Therapeutics USA, Inc.

CD19-directed Cytolytic Antibody [EPC]

12.1 Mechanism of Action The mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD, IgG4-RD, and gMG is presumed to involve bin...

FDA label ↗

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Clinical Trial Landscape

No active clinical trials currently recruiting for Transient neonatal myasthenia gravis.
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Recent News & Research

1 article
Diagnostics (Basel, Switzerland)Mar 28, 2026

Myasthenia Gravis in Pregnancy: Prenatal and Postnatal Diagnostic Challenges-A Narrative Review.

Myasthenia gravis (MG) is a prevalent autoimmune disorder affecting neuromuscular junctions, typically characterized by muscle weakness due to autoantibodies targeting acetylcholine receptors (AChR) o...

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Specialist Network

Top 6 by expertise

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