US EditionFDA approves self-injection of Vyvgart Hytrulo
- The FDA approved a new way to administer efgartigimod via a pre-filled syringe in April.
- This approval provides another option to deliver efgartigimod, already approved for MG and CIDP.
- The pre-filled syringe is designed for at-home use and expands administration options.
- A phase 1 study with 120 adults aged 55+ confirmed the syringe's safety and bioequivalence.
- This approval offers greater patient convenience, flexibility, and may reduce infusion-related adverse events.
26 Articles
26 Articles
Watauga Democrat
FDA Approves Self-Injection of Vyvgart Hytrulo
WEDNESDAY, April 16, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor…
FDA approves self-injection of Vyvgart Hytrulo
The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
NeuroVoices: Beth Stein, MD, on Implications of Newly Approved Pre-Filled Syringe Option for Efgartigimod
Beth Stein, MD, director of neuromuscular diseases at St. Joseph’s Health, shared insights on the impact of a newly approved pre-filled syringe formulation of efgartigimod, highlighting its potential to transform care delivery.
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