argenx Announces MHRA Licensing of Subcutaneous VYVGART® ▼ (efgartigimod alfa) for generalised Myasthenia Gravis

argenx Announces MHRA Licensing of Subcutaneous VYVGART® ▼ (efgartigimod alfa) for generalised Myasthenia Gravis

VYVGART® is now licensed for both intravenous (IV) and self-administered subcutaneous (SC) use in the UK

Gerrards Cross, UK —[7th February 2024] —argenx UK Ltd, part of argenx (Euronext & Nasdaq:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced today that the MHRA has licensed SC injectable VYVGART (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The MHRA previously licensed efgartigimod IV in March 2023. Following this decision efgartigimod is now licensed in the UK for both IV and SC use including possible SC self-administration.

Doctor Sivakumar Sathasivam, Consultant Neurologist and Myasthenia Gravis lead, The Walton Centre, Liverpool commented: ‘’There is a clear unmet need for an effective therapy that can be used to manage gMG patients whose symptoms remain significantly uncontrolled despite established clinical management. Subcutaneous efgartigimod provides a new and easier-to-administer treatment option for these people, with the ability to potentially impact their quality of life and disease burden.’’

The UK license follows approval by the EC in November 2023 and is based on positive results from the Phase 3 ADAPT-SC study. ADAPT- SC established the efficacy of SC efgartigimod by demonstrating a reduction in anti-AChR antibody levels comparable to efgartigimod IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of efgartigimod IV in Europe in August 2022.

“Today’s authorisation marks another important step forward for the management of gMG in the UK, offering a simpler way to administer efgartigimod, through a subcutaneous injection,” said David Knechtel, General Manager of argenx UK Ltd. “argenx is continually looking at how we can help improve the care of people living with gMG and our hope is that this may provide greater flexibility and choice to physicians, and their patients. Our focus now will be on ensuring seamless access to this medicine for all those who could potentially benefit, and we are working closely with authorities across the UK to make this a reality.”