efgartigimod alfa + hyaluronidase

Efgartigimod PH20 is a subcutaneous co-formulation of efgartigimod alfa, a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), and recombinant human hyaluronidase PH20 (rHuPH20). Developed by argenx using Halozyme's ENHANZE technology, it is designed to reduce circulating immunoglobulin G (IgG) levels by blocking FcRn-mediated recycling. This mechanism is utilized to treat IgG-mediated autoimmune diseases. While efgartigimod alfa was initially approved for intravenous use (Vyvgart), the PH20 formulation (Vyvgart Hytrulo) allows for rapid subcutaneous administration. It is approved for generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). However, clinical development for pemphigus vulgaris and pemphigus foliaceus was discontinued following the failure of the Phase 3 ADDRESS trial to meet its primary endpoint.

Brand names

Vyvgart Hytrulo

Other names

efgartigimod PH20efgartigimod alfa and hyaluronidase-qvcp