Efgartigimod alfa/hyaluronidase explained

Efgartigimod alfa/hyaluronidase, sold under the brand name Vyvgart Hytrulo, is a coformulation medication used for the treatment of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. It contains efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase (human recombinant), an endoglycosidase.

Efgartigimod alfa/hyaluronidase may increase the risk of infection, including urinary tract infection and respiratory tract infections. In clinical trials, hypersensitivity reactions, including rash, angioedema (swelling), dyspnea (shortness of breath), and urticaria (itchy welts) were observed in people treated with efgartigimod alfa. The most common adverse reactions (≥ 10%) of people with myasthenia gravis treated with efgartigimod alfa were respiratory tract infections, headache, and urinary tract infection.

It was approved for medical use in the United States in June 2023.^{[2] [3]}

Medical uses

Efgartigimod alfa/hyaluronidase is indicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.

In June 2024, the US Food and Drug Administration (FDA) expanded the indication for the combination to include the treatment of chronic inflammatory demyelinating polyneuropathy in adults.^[4]

History

The effectiveness of the combination for the treatment of adults with chronic inflammatory demyelinating polyneuropathy was established in a two stage, multicenter study (Study 3; NCT04281472). Study 3 included an open-label period (stage A) to identify people who had evidence of improvement with the use of Vyvgart Hytrulo, who then entered a randomized, double-blind, placebo-controlled, withdrawal period (stage B).

Notes and References

1. Web site: Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase- human recombinant injection, solution . DailyMed . 21 June 2023 . 29 August 2023.
2. Halozyme Announces argenx Receives FDA Approval for Vyvgart Hytrulo With Enhanze for Subcutaneous Use in Generalized Myasthenia Gravis . Halozyme Therapeutics . PR Newswire . 20 June 2023 . 24 June 2023.
3. Argenx Announces U.S. Food and Drug Administration Approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis . Argenx . 20 June 2023 . 24 June 2023.
4. Web site: FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults . U.S. Food and Drug Administration (FDA) . 24 June 2024 . 25 June 2024.