FDA Pushes Back Decision Date on Argenx BLA to June

The FDA has extended its decision date on argenx’s biologics license application (BLA) for subcutaneous efgartigimod for the treatment of adults with generalized myasthenia gravis to June 20.

The agency needed more time to review information submitted in connection with the ongoing review that “constituted a major amendment,” the company said.

Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies, blocking the IgG recycling process. The drug 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.

The company said that that agency has not asked for any additional data or studies this time.