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Also known as Efgartigimod IV or Efgartigimod PH20 SC
Efgartigimod or Efgartigimod PH20 · 1 trial · 2 indications
AE : adverse event; SAE : serious adverse event; AESI : adverse event of special interest
| Arm | Type | Description |
|---|---|---|
| Efgartigimod or Efgartigimod PH20 SC | EXPERIMENTAL | Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment |
| Name | Type | Description |
|---|---|---|
| Efgartigimod IV or Efgartigimod PH20 SC | BIOLOGICAL | Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC |
Inclusion Criteria: * The participant completed ARGX-113-2006, defined as: 1. The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial. 2. The participant qualifies for retreatment in trial ARGX-113-2006, ...
Efgartigimod, also known as Efgartigimod PH20, is an investigational monoclonal antibody being studied for the treatment of generalized Myasthenia Gravis (gMG) in children. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Efgartigimod targets the neonatal Fc receptor (FcRn). By blocking this receptor, it reduces levels of pathogenic IgG antibodies that contribute to the autoimmune attack in generalized Myasthenia Gravis. This mechanism is being evaluated in an ongoing Phase 2 clinical trial.
Efgartigimod is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARGX. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in pediatric patients with generalized Myasthenia Gravis.
Efgartigimod is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is designed to evaluate the long-term safety of Efgartigimod administered intravenously and Efgartigimod PH20 administered subcutaneously in children with generalized Myasthenia Gravis.
Efgartigimod is being studied in a Phase 2 clinical trial registered as NCT05374590. This trial is evaluating the long-term safety of Efgartigimod administered intravenously and Efgartigimod PH20 administered subcutaneously in children with generalized Myasthenia Gravis. The trial is enrolling by invitation and aims to enroll 12 participants across multiple countries.
Yes, Efgartigimod and Efgartigimod PH20 are related forms of the same drug. Efgartigimod is administered intravenously, while Efgartigimod PH20 is a subcutaneous formulation. Both are being evaluated in the same Phase 2 clinical trial for the treatment of generalized Myasthenia Gravis in children.