BLAINJECTIONINJECTABLEPriority Review
Approved
Jun 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
Priority Review
VYVGART HYTRULO (efgartigimod alfa and hyaluronidase (human recombinant)) by argenx is neonatal fc receptor blockers [moa]. Approved for endoglycosidase [epc]. First approved in 2023.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYVGART HYTRULO is an injectable biologic combining efgartigimod alfa (an neonatal Fc receptor blocker) with recombinant human hyaluronidase for subcutaneous administration. It treats generalized myasthenia gravis (gMG) by reducing pathogenic autoantibodies that attack the neuromuscular junction. The hyaluronidase component enables subcutaneous delivery of the monoclonal antibody fragment, improving patient convenience over IV administration.
$9MPart D
GrowthEarly commercialization phase with modest current uptake (170 Part D claims in 2023) presents opportunity for commercial team expansion as gMG awareness and adoption grow.
Mechanism of Action
Neonatal Fc Receptor Blockers
Pharmacologic Class:
Endoglycosidase
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
Started Jan 2026
25 enrolled
Myasthenia Gravis Generalized
Why This Matters for Your Career
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.