argenx announces UK MHRA approval of VYVGART for the treatment of generalized myasthenia gravis
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for VYVGART® (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with gMG who are AChR antibody positive (1).
“We are pleased to announce this latest regulatory approval of VYVGART, another exciting advancement toward our vision of making our innovation available to as many patients as possible," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “As we seek to redefine the treatment of this debilitating disease, we look forward to close collaboration with the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) to support broad and rapid access to this new treatment option, connecting eligible gMG patients in the UK to the care they need.”
The MHRA approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale following treatment with efgartigimod compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle (2).
There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.
VYVGART had a demonstrated safety profile in the ADAPT clinical trial. The most commonly reported adverse reactions that occurred more frequently with VYVGART than placebo were upper respiratory tract infections (10.7% following treatment with efgartigimod vs. 4.8% of placebo) and urinary tract infections (9.5% vs. 4.8%).
“gMG can impact patients and caregivers in every area of life – many are faced with the difficult choice of taking significant time away from work, giving up hobbies or spending less time with their loved ones. VYVGART is the first-and-only FcRn blocking treatment to receive approval in UK, offering patients and their families a new treatment option that is targeted to the underlying pathogenesis of the disease and supported by strong efficacy, safety and tolerability data,” said Prof Saiju Jacob, Consultant Neurologist at the University Hospitals Birmingham. “The marketing authorization of VYVGART is great news for the gMG community in the UK, providing a newer treatment option which along with the existing drugs will hopefully reduce the burden of this debilitating disease.”
VYVGART was granted a Promising Innovative Medicine (PIM) designation by the MHRA in November 2021, as well as a positive scientific opinion under the Early Access to Medicines Scheme in May 2022.
(1) VYVGART UK Summary of Product Characteristics
(2) Howard JF et al. Lancet Neurol 2021;20(7):526-536.