Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

Argenx is preparing for expanded FDA approval of Vyvgart (efgartigimod alfa), specifically via a prefilled syringe formulation, with an FDA action date set for April 10, 20251 5.

Recent FDA approval enables Vyvgart Hytrulo, the subcutaneous self-injectable form, to treat adults with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy (CIDP), allowing for easier patient self-administration3 5.

The planned launch of the prefilled syringe is part of Argenx's strategy to move Vyvgart earlier in the treatment line for gMG and capitalize on the momentum of the CIDP indication, which was FDA approved in 20241 4.

Vyvgart Hytrulo's expanded indications are supported by clinical trial data showing favorable safety and comparable efficacy to existing intravenous formulations2 5.

The self-injectable Vyvgart Hytrulo offers patients more autonomy, flexibility, and independence in disease management, potentially expanding its reach to a broader population with myasthenia gravis5.