Argenx Submits BLA for Generalized Myasthenia Gravis

Argenx has submitted a Biologics License Application (BLA) for subcutaneous efgartigimod for treatment of adult patients with generalized myasthenia gravis, a rare and chronic autoimmune disease that leads to muscle weakness.

The BLA submission is based on results from a phase 3 study that demonstrated the drug’s noninferiority compared to the company’s FDA-approved intravenous drug Vyvgart (efgartigimod alfa-fcab).

Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by blocking the IgG recycling process. It is co-formulated with Halozyme Therapeutics’ Enhanze drug delivery technology, under a collaboration and licensing deal inked in February 2019.