RARE Daily

European Commission Approves Argenx Vygart for Generalized Myasthenia Gravis

November 16, 2023

Rare Daily Staff

The European Commission approved Argenx’s subcutaneous injectable Vygart as an add-on to standard therapy for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85 percent of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed anti-acetylcholine receptor (AChR) antibodies account for approximately 85 percent of the total gMG population.

The EC previously approved Vygart IV in August 2022. Following this decision, Vygart is now approved in Europe for both IV and self-administered SC use. The approval is applicable to all 27 European Union (EU) Member States plus Iceland, Norway, and Liechtenstein. Argenx will work with local health authorities to secure patient access for Vygart SC in the region.

“The availability of two formulations, including the possibility for patients to self-administer at home, allows people living with gMG to choose the treatment that best works for their lifestyle, further reinforcing the individualized treatment approach offered by Vygart,” said Anant Murthy, general manager of Argenx EMEA.

The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the phase 3 ADAPT-SC study. ADAPT- SC established the efficacy of Vygart SC by demonstrating a reduction in anti-AChR antibody levels comparable to Vygart IV in adult gMG patients. ADAPT-SC was a bridging study to the phase 3 ADAPT study, which formed the basis for approval of Vygart IV in Europe in August 2022.

VYVGART SC is a SC injectable formulation of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as Vygart. It is formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology, to facilitate SC injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), Vygart results in the reduction of circulating IgG autoantibodies. Vygart SC was approved in the United States in June 2023 and is marketed as Vygart Hytrulo.

Photo: Anant Murthy, general manager of Argenx EMEA

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