SC Injectable Vyvgart Hytrulo Gets FDA Nod for Generalized Myasthenia Gravis

The Food and Drug Administration (FDA) has approved Vyvgart^® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Vyvgart Hytrulo is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase. Hyaluronidase increases permeability of the subcutaneous (SC) issue allowing for SC injection of the biologic product.

The approval was based on data from the randomized, open-label, parallel-group phase 3 ADAPT-SC study (ClinicalTrials.gov Identifier: NCT04735432), which compared the efficacy and safety of SC efgartigimod to IV efgartigimod (Vyvgart) in adults with gMG.

Results showed that treatment with SC efgartigimod was noninferior to IV efgartigimod (primary endpoint; P <.0001). At day 29, the mean total IgG reduction was 66.4% and 62.2% in the SC efgartigimod and IV efgartigimod groups, respectively.

“The clinical trials of Vyvgart continue to show significant benefit to patients with a favorable safety profile and clear improvements in gMG disease scores,” said James F. Howard Jr, MD, Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine and Principal Investigator for the ADAPT-SC trial. “Now with the approval of Vyvgart Hytrulo, we have a broad gMG treatment offering with both IV and SC administration options and can select based on patient needs and preference without sacrificing clinical benefit or safety.”

Vyvgart Hytrulo is administered subcutaneously only by a health care professional using a winged infusion set. The product is supplied as a solution containing 1008mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6mL in a single-dose vial. It is expected to be available in July 2023.