FDA Approves Vyvgart Hytrulo Prefilled Syringe With Self-Injection for Generalized Myasthenia Gravis, CIDP

Author(s):

Luke Halpern, Assistant Editor

Key Takeaways

FDA approved efgartigimod alfa and hyaluronidase-qvfc prefilled syringe for self-injection in gMG and CIDP patients, enhancing treatment accessibility.
The prefilled syringe allows for rapid, high-volume delivery, demonstrating bioequivalence to the vial form, and supports self-administration.
Pharmacists are crucial in counseling patients on administration options, ensuring proper guidance and adherence to treatment regimens.
The approval of this combination regimen as a prefilled syringe removes the need for dilution, simplifying administration and potentially improving patient outcomes.

The new indication expands administration methods for the combination of efgartigimod alfa and hyaluronidase-qvfc, which are already approved for the treatment of some immune-related conditions.

The FDA granted regulatory approval to efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo; argenx) prefilled syringe for self-injection for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and those with chronic inflammatory demyelinating polyneuropathy (CIDP), according to a news release from Halozyme Therapeutics.¹

Medical syringe for liquid 5 ml. White medical syringe with a cap, isolated on a blue background.

Image Credit: © iKatod - stock.adobe.com

Prefilled efgartigimod alfa and hyaluronidase-qvfc was approved for use as a 20-to-30-second subcutaneous injection, administered by a health care professional, caregiver, or the patient themselves. Notably, patients can self-inject the treatment, following proper counseling in subcutaneous injection technique.¹

Previously, efgartigimod alfa was granted regulatory approval in patients with gMG, becoming the first and only FDA-approved neonatal Fc receptor blocker for use in this population. Efgartigimod was also approved in combination with hyaluronidase-qvfc for the treatment of adults with CIDP, being administered once weekly through a subcutaneous injection. The availability of a novel administration mechanism for this combination will allow for the rapid and high-volume delivery of efgartigimod alfa and hyaluronidase-qvfc and lead to better patient outcomes.^1-3

"The FDA approval of [efgartigimod alfa and hyaluronidase-qvfc] prefilled syringe represents a significant advancement in treatment options for gMG and CIDP patients, enabling self-administration by patients and potentially further reducing the burden of treatment," Helen Torley, president and CEO of Halozyme, said in the news release.¹

Study results garnered by investigators support the approval of an efgartigimod alfa and hyaluronidase-qvfc prefilled syringe for self-injection, which demonstrated bioequivalence to the combination in a vial, according to the news release. Furthermore, human factors validation studies have found that patients with gMG or CIDP or their caregivers had vast success and safety while preparing and administering the prefilled syringe of efgartigimod alfa and hyaluronidase-qvfc, an important development that contributed to the FDA’s regulatory action.¹

Efgartigimod alfa, a human immunoglobulin G1 (IgG1) antibody fragment, is designed to bind to a patient’s neonatal Fc receptor, inducing the reduction of circulating IgG levels in the body. The recommended dose for efgartigimod infusions is 10 mg per kg, administered intravenously over 1 hour, typically once weekly across a 4-week period. In combination with hyaluronidase, the recommended dosage is 1008 mg per 11,200 units every 4 weeks. When used in its intravenous (IV) form, treatment with efgartigimod alfa requires the solution to be diluted with 0.9% sodium chloride injection. The approval of this combination regimen as a prefilled syringe removes this obstacle and could allow for easier administration.^1,4

Pharmacists stand to play a crucial role in counseling and educating patients with gMG or CIDP on administration options for efgartigimod alfa and hyaluronidase-qvfc. Patients will now have more treatment options for their conditions and will rely on their providers to properly guide them towards the proper method of administration that works best for them based on their disease presentation and other burdens.¹

REFERENCES

1. Halozyme. Halozyme announces FDA approval of argenx’s VYVGART Hytrulo prefilled syringe co-formulated with ENHANZE for self-injection for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. News Release. Released April 10, 2025. Accessed April 14, 2025. https://ir.halozyme.com/news/news-details/2025/Halozyme-Announces-FDA-Approval-of-argenxs-VYVGART-Hytrulo-Prefilled-Syringe-Co-Formulated-with-ENHANZE-for-Self-Injection-for-Generalized-Myasthenia-Gravis-and-Chronic-Inflammatory-Demyelinating-Polyneuropathy/default.aspx?_gl=16uuz3e_upMQ.._gaNjYxNTYxNDUzLjE3NDQ2NTM0Njc._ga_T1NMWLFHFZMTc0NDY1MzQ2NS4xLjEuMTc0NDY1MzQ2OS4wLjAuMA.._ga_VXX5W0L85Q*MTc0NDY1MzQ2Ni4xLjEuMTc0NDY1MzQ2OS4wLjAuMA

2. Murphy J. FDA approves efgartigimod alfa-fcab for generalized myasthenia gravis. Pharmacy Times. Published December 20, 2021. Accessed April 14, 2025. https://www.pharmacytimes.com/view/fda-approves-efgartigimod-alfa-fcab-for-generalized-myasthenia-gravis

3. Halpern L. FDA approves efgartigimod alfa and hyaluronidase-qvfc for chronic inflammatory demyelinating polyneuropathy. Pharmacy Times. Published July 1, 2024. Accessed April 14, 2025. https://www.pharmacytimes.com/view/fda-approves-efgartigimod-alfa-and-hyaluronidase-qvfc-for-chronic-inflammatory-demyelinating-polyneuropathy.

4. Arakelians S. Efgartigimod alfa provides much-needed treatment options for patients with generalized myasthenia gravis. Pharmacy Times. Published August 29, 2024. Accessed April 14, 2025. https://www.pharmacytimes.com/view/efgartigimod-alfa-provides-much-needed-treatment-options-for-patients-with-generalized-myasthenia-gravis