Vyvgart Hytrulo FDA Approval History
Last updated by Judith Stewart, BPharm on April 14, 2025.
FDA Approved: Yes (First approved June 20, 2023)
Brand name: Vyvgart Hytrulo
Generic name: efgartigimod alfa and hyaluronidase-qvfc
Dosage form: Injection
Company: Argenx SE
Treatment for: Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is a neonatal Fc receptor blocker and endoglycosidase combination used for the treatment of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
- Vyvgart Hytrulo is indicated for the treatment of adult patients with:
- generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive
- chronic inflammatory demyelinating polyneuropathy (CIDP). - Generalized myasthenia gravis is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. CIDP is a rare and often progressive immune-mediated neuromuscular disorder of the peripheral nervous system characterized by gradually increasing sensory loss and weakness associated with loss of reflexes.
- Efgartigimod alfa is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) antibodies. Efgartigimod alfa was first approved for the treatment of anti-AChR antibody positive gMG under the brand name Vyvgart in 2021. Vyvgart is administered as an intravenous infusion over one hour.
- Vyvgart Hytrulo is a combination of efgartigimod alfa (Vyvgart), and recombinant human hyaluronidase PH20 (rHuPH20) which facilitates the subcutaneous delivery of biologics.
- Vyvgart Hytrulo is supplied as:
- Single-dose prefilled syringe containing 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase per 5 mL (200 mg/2,000 units per mL)
- Single-dose vial containing 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL)
Vyvgart Hytrulo in the prefilled syringe is self-administered or administered by a caregiver subcutaneously over 20 to 30 seconds.
Vyvgart Hytrulo in the vial is administered by a healthcare professional subcutaneously over 30-90 seconds. - Warnings and precautions associated with Vyvgart Hytrulo include infections and hypersensitivity reactions.
- Common adverse reactions (≥ 10%) in patients with gMG treated with Vyvgart include respiratory tract infections, headache, and urinary tract infection.
Common adverse reactions (≥ 15%) in patients with gMG/CIDP treated with Vyvgart Hytrulo include injection site reactions.
Development timeline for Vyvgart Hytrulo
Further information
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