Argenx Announces EC Approval For Subcutaneous Vyvgart For Generalized Myasthenia Gravis

(RTTNews) - Immunology company Argenx SE (ARGX) Thursday announced that the European Commission or EC approved self-administered subcutaneous or SC injectable Vyvgart or efgartigimod alfa as an add-on to standard therapy for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

Vyvgart SC is a SC injectable formulation of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use. Earlier in August 2022, the EC had approved Vyvgart IV.

The EC approval for the second formulation is based on positive results from the Phase 3 ADAPT-SC study and a positive recommendation from the Committee for Medicinal Products for Human Use or CHMP.

Anant Murthy, General Manager of Argenx EMEA said today's approval reflects its commitment to providing a choice of effective, innovative therapies to people with autoimmune diseases.

The availability of two formulations, and the possibility for patients to self-administer at home, allows people living with generalized myasthenia gravis to choose the treatment that best works for their lifestyle, the company noted.

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.