efgartigimod alfa
Orphan Drug Cold Chain RequiredFDA Approved (2021), EMA Approved (2022), Japan Approved (2022)
Description
Efgartigimod alfa is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), reducing pathogenic IgG antibodies. It is approved for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. The drug offers a novel mechanism targeting the underlying autoantibody pathology with intravenous infusion cycles.
Indications & Therapeutic Use
Generalized myasthenia gravis (gMG) in AChR antibody-positive adults
Linked Diseases:
myasthenia gravis
D009157
Global Availability (6 countries)
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Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
efgartigimod alfa
| Generic Name | efgartigimod alfa |
| Brands | 1 brand available |
| Active Ingredient | efgartigimod alfa-fcab |
| Drug Class | Generalized myasthenia gravis (gMG) in AChR antibody-positive adults |
| Manufacturer | argenx |
| Dosage Forms | Intravenous infusion, 400mg/20mL solution |
| Medical Code | L04AA52 |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Required |
| Lead Time | 14 days |
| Reg. Status | FDA Approved (2021), EMA Approved (2022), Japan Approved (2022) |
| Clinical Trial | NCT03669588 |
| Countries | 6 countries |
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations7 Validated Nodes