Pharma Focus Europe

Argenx Granted FDA Approval for VYVGART Hytrulo (Efgartigimod Alfa and Hyaluronidase-qvfc) Injection in Generalized Myasthenia Gravis

Wednesday, June 21, 2023

Argenx SE, a global immunology company focused on enhancing the lives of individuals with severe autoimmune diseases, has recently received approval from the U.S. Food and Drug Administration (FDA) for VYVGART Hytrulo. This newly approved medication is intended for the treatment of generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor (AChR) antibodies. It is estimated that approximately 85% of the total gMG population falls into this category.

VYVGART Hytrulo is a subcutaneous injection that combines efgartigimod alfa, a human IgG1 antibody fragment marketed as VYVGART for intravenous use, with recombinant human hyaluronidase PH20 (rHuPH20), which utilizes Halozyme's ENHANZE® drug delivery technology to facilitate the subcutaneous delivery of biologics. Healthcare professionals administer the product as a single injection of 1,008 mg over 30-90 seconds, once a week for four weeks.

Luc Truyen M.D., Ph.D., the Chief Medical Officer at argenx, expressed his enthusiasm regarding the approval, stating that it signifies a significant milestone in redefining treatment options for gMG patients. He also emphasized the company's commitment to the gMG community by providing more choices and flexibility in how patients can receive treatment. By offering both an infusion and subcutaneous injection option, argenx aims to provide an individualized treatment approach that enables patients to remain symptom-free while choosing the method and location of treatment that best suits their needs.

Allison Foss, the Executive Director of the Myasthenia Gravis Association, hailed the availability of another treatment option from argenx as a meaningful advancement for the patient community. The introduction of a subcutaneous delivery option provides patients with increased flexibility and the freedom to choose between treatment at an infusion center, at home, or at a physician's office. This choice can significantly improve daily living for gMG patients and their caregivers.

The approval of VYVGART Hytrulo was based on positive results from the Phase 3 ADAPT-SC study, which demonstrated comparable reductions in anti-AChR antibody levels to intravenous VYVGART in adult gMG patients. The study successfully met its primary endpoint of noninferiority (p<0.0001), and VYVGART Hytrulo exhibited a mean total IgG reduction of 66.4% from baseline at day 29, similar to the 62.2% reduction observed with VYVGART. Key secondary endpoints were also met, corroborating the efficacy measures from the ADAPT study and establishing the correlation between total IgG reduction and clinical benefits in gMG.

VYVGART Hytrulo demonstrated a favorable safety profile consistent with the ADAPT clinical trial, with the exception of higher rates of injection site reactions (ISRs). These ISRs, which are commonly observed with subcutaneously administered biologics, were generally mild to moderate and resolved over time.

The anticipated availability of VYVGART Hytrulo for U.S. patients is set for July 2023. argenx is committed to ensuring patient access to its medications and has decided to price VYVGART Hytrulo at the same level as VYVGART on a net annual revenue basis.

To support patients throughout their treatment journey, argenx offers the My VYVGART Path program, which provides resources such as disease and product education, access support, benefits verification, and financial assistance programs for eligible patients. Patients and clinicians seeking more information can visit VYVGARTHytrulo.com.

argenx has submitted marketing authorization applications for SC efgartigimod to the European Medicines Agency, with a decision expected by the end of 2023, and to Japan's Pharmaceuticals and Medical Devices Agency (PMDA), with a decision expected by the first quarter of 2024.

In conclusion, the approval of VYVGART Hytrulo provides gMG patients with an additional treatment option and showcases argenx's dedication to improving the lives of those with severe autoimmune diseases.

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