FDA Extends Review of Argenx BLA

FDA has extended by three months its review of an Argenx BLA for subcutaneous efgartigimod for treating adult patients with generalized myasthenia gravis. The revised user fee review action target date is 6/20.

The agency told the company that recently submitted information constituted a major amendment and requires a review extension to evaluate. No additional data or studies have been requested at this time, the company says.

Argenx describes efgartigimod as an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. “Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an intravenous and subcutaneous (SC) formulation,” it says.