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MHRA licenses treatment option for rare autoimmune disease

The Medicines and Healthcare products Regulatory Agency (MHRA) has licensed argenx UK’s subcutaneous VYVGART® ▼ as an add-on to standard therapy in adult patients who are anti-acetylcholine receptor antibody positive, for the treatment of generalised Myasthenia Gravis, a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness.

The MHRA previously licensed efgartigimod IV in March 2023. Following this decision efgartigimod is now licensed in the UK for both IV and subcutaneous use including possible subcutaneous self-administration.

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 was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of efgartigimod IV in Europe in August 2022.

Doctor Sivakumar Sathasivam, Consultant Neurologist and Myasthenia Gravis lead, The Walton Centre, Liverpool said: “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.”

David Knechtel, General Manager of argenx UK Ltd said: “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. 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.”

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