VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)
VYVGART HYTRULO is indicated for the treatment of Myasthenia Gravis; Chronic Inflammatory Demyelinating Polyneuropathy.
How VYVGART HYTRULO Works
The medication consists of efgartigimod alfa, which binds to the neonatal Fc receptor (FcRn) to reduce circulating IgG levels. By blocking this receptor, the drug decreases the presence of antibodies that contribute to disease pathology. The second component, hyaluronidase, is an endoglycosidase that depolymerizes hyaluronan to increase the permeability of subcutaneous tissue. This effect facilitates drug delivery and is transient, with tissue permeability returning to normal within 24 to 48 hours.
Details
- Status
- Prescription
- First Approved
- 2023-06-20
- Patent Cliff
- 2031
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VYVGART HYTRULO Approval History
What VYVGART HYTRULO Treats
2 indicationsVYVGART HYTRULO is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myasthenia Gravis
- Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART HYTRULO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VYVGART HYTRULO FDA Label Details
Indications & Usage
FDA Label (PDF)VYVGART HYTRULO is indicated for the treatment of Myasthenia Gravis; Chronic Inflammatory Demyelinating Polyneuropathy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.