Vyvgart Hytrulo FDA Approval History
Last updated by Judith Stewart, BPharm on June 27, 2023.
FDA Approved: Yes (First approved June 20, 2023)
Brand name: Vyvgart Hytrulo
Generic name: efgartigimod alfa and hyaluronidase-qvfc
Dosage form: Injection
Company: Halozyme Therapeutics, Inc.
Treatment for: Myasthenia Gravis
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is a neonatal Fc receptor blocker and endoglycosidase combination indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
- 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.
- 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 in cycles of once weekly infusions for 4 weeks.
- Vyvgart Hytrulo is a combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), which is Halozyme's ENHANZE® drug delivery technology that facilitates subcutaneous delivery of biologics. Vyvgart Hytrulo is administered subcutaneously by a healthcare professional as a single injection over 30-90 seconds in cycles of once weekly injections for 4 weeks.
- 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
| Date | Article |
|---|---|
| Jun 20, 2023 | Approval FDA Approves Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Subcutaneous Use in Generalized Myasthenia Gravis |
Further information
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