argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions
02 Nov 2023
Clinical ResultDrug ApprovalVaccineImmunotherapy
Long-term clinical trial and real-world data illustrate VYVGART® drives consistent, repeatable and clinically meaningful responses, including minimal symptom expression (MSE) in generalized myasthenia gravis (gMG)
Patients treated with VYVGART experienced consistent improvements on key quality of life measures based on long-term gMG extension data
Data across multiple indications and dosing schedules confirm favorable safety profile and no increase in treatment-emergent adverse event rates with longer exposure
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced 20 presentations of clinical trial and real-world data from studies of VYVGART® and VYVGART Hytrulo® (VYVGART) in neuromuscular autoimmune disease. The data presentations will be featured at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session, taking place in Phoenix, AZ from November 1-4, 2023.
“As leaders in the field of FcRn inhibition, we continue to generate deep and broad data from our clinical trials, including long-term extension and real-world evidence studies,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "With VYVGART for gMG, we continue to show favorable safety and consistent, repeatable clinically meaningful responses, including the ability of patients to achieve MSE, across three years of treatment. The ADHERE study, the largest in the history of CIDP, further demonstrates our commitment to the neuromuscular community. These data characterize the broad impact our first-in-class FcRn blocker can have on the lives of people living with CIDP, and our work to establish its safety and efficacy in the treatment of CIDP represents an exciting step forward for this community.”
Highlights from Data Presented at AANEM and MGFA
Consistent, Repeatable Responses: Long-term clinical data from ADAPT+ and ADAPT-SC+ and real-world data illustrate the ability of VYVGART to provide consistent, repeatable, and clinically meaningful responses across more than 19 cycles, including improvements in quality-of-life measures, for anti-acetylcholine receptor (AChR) antibody positive patients with gMG.
Achievement of Minimal Symptom Expression: Treatment with VYVGART resulted in 40.5% - 44.6% of patients achieving MSE in ADAPT and ADAPT+. Patients achieving MSE reported quality of life measures comparable to healthy populations. Similar results were demonstrated in ADAPT-SC+ with 35.5%-40.7% of patients achieving MSE following treatment with VYVGART Hytrulo.
ADHERE Results: Positive topline results from the ADHERE study of VYVGART Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) were first reported in July 2023 and are being presented again during the conference. The full dataset from ADHERE will be presented at a medical meeting in 2024.
Vaccine Response: Study participants were able to mount effective humoral immune responses to polyvalent pneumococcal vaccine regardless of whether administered during or after VYVGART administration.
Seronegative Population: Long-term treatment with VYVGART Hytrulo was associated with consistent and repeatable improvements on MG-ADL and MG-QoL15r scales in seronegative (anti-AChR antibody negative) gMG patients.
Favorable Safety Profile: VYVGART shows consistency of safety across multiple indications with TEAE rates that were comparable to placebo, mostly mild to moderate in severity and did not increase with longer exposure.
Additional data are being presented from case studies of gMG patients with LRP4 antibodies, a meta-analysis of quality-of-life outcomes of VYVGART and other gMG treatments, and argenx-sponsored health economic outcomes research studies demonstrating gMG patients facing social-determinants of health challenges experience health inequities related to increased utilization of acute care facilities, and delayed diagnosis and access to treatment.
About Generalized Myasthenia Gravis
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% of people with MG progress to gMG within 24 months,1 where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.1
About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair.
About VYVGART
VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU and China for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).
About VYVGART® Hytrulo
VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection.
VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
References
1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277.
The content above comes from the network. if any infringement, please contact us to modify.
Organizations
Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.