Vyvgart Hytrulo FDA Approval History
Last updated by Judith Stewart, BPharm on June 24, 2024.
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; and
- 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 and recombinant human hyaluronidase PH20 (rHuPH20) which facilitates the subcutaneous delivery of biologics. Vyvgart Hytrulo is administered subcutaneously by a healthcare professional as a single injection over 30-90 seconds.
- Warnings and precautions associated with Vyvgart Hytrulo include infections and hypersensitivity reactions.
- Common adverse reactions in patients with gMG treated with Vyvgart include respiratory tract infections, headache, and urinary tract infection. Additional common adverse reactions in patients treated with Vyvgart Hytrulo include injection site reactions.
Development timeline for Vyvgart Hytrulo
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
