Full Press Release Details
argenx Demonstrates Commitment to Redefining
Treatment Goals for Generalized Myasthenia Gravis with Multiple Presentations at American Academy of Neurology 2023 Annual Meeting
Amsterdam, the Netherlands - 04/18/2023
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced that it will present six abstracts further demonstrating its long-term commitment to the generalized
myasthenia gravis (gMG) community during the 75th American Academy of Neurology (AAN) Annual Meeting, which is taking place from April 22-27,
2023 in Boston, MA. The presentations include clinical and real-world efgartigimod data that demonstrate the potential of neonatal Fc
receptor (FcRn) blockade in transforming treatment for gMG and other IgG-mediated autoimmune diseases.
"Our presentations at AAN will showcase
the depth of evidence we are generating in support of the clinical and real-world profile of efgartigimod to address the often-underappreciated
needs of people living with gMG," said Luc Truyen, M.D. Ph.D., Chief Medical Officer, argenx. "We have a unique opportunity
to recalibrate expectations for patients and their supporters by setting a new standard for what well-controlled' means in
gMG and across autoimmunity more broadly."
Power of Individualized Dosing from Long-term
The presentations include results from the open-label
extension studies of VYVGART (efgartigimod alfa-fcab) and subcutaneous (SC) efgartigimod following long-term treatment
in ADAPT+ (217.5 patient-years follow-up) and ADAPT-SC+ (72 patient-years follow-up). Long-term treatment, administered in individualized
dosing cycles, led to consistent and repeatable reductions in IgG antibody levels and improved clinical outcomes.
A cross-indication review of the safety profile
of efgartigimod will also be presented across multiple IgG-mediated autoimmune diseases, reinforcing the consistent safety profile observed
Potential in Patients Early in gMG Disease
analysis will be presented from the ADAPT Phase 3 trial showing that a greater percentage of gMG patients with fewer than three years
disease duration were responders and achieved minimum symptom expression (MSE) compared with placebo.
New Opportunities with Patient Support Programs
of its commitment to address access for gMG patients impacted by social determinants of health challenges, argenx will present quantitative
and qualitative research that identified potential opportunities to expand patient support program offerings, including the establishment
of an information hotline and symptom tracking app, a patient mentoring program, an innovative giving strategy and broadened awareness
campaigns of nurse case manager services.
Details for the poster presentations are as
Title: Long-Term Safety, Tolerability,
And Efficacy of Efgartigimod in Patients with Generalized Myasthenia Gravis: Concluding Analyses from the ADAPT+
Session Date & Time: Oral Presentation
- Sunday, April 23 at 2:00pm ET
Presenter: Dr. Mamatha Pasnoor
Abstract Number: S5.006
Title: Long-Term Safety, Tolerability,
and Efficacy of Subcutaneous Efgartigimod PH20 in Patients with Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study
Session Date & Time: Poster Session
1, Sunday, April 23, 8-9 am ET
Presenter: Dr. James F. Howard
Abstract Number: P1.5-014
Title: Dose Selection and Clinical Development
of Efgartigimod Ph20 Subcutaneous Inpatients With Generalized Myasthenia Gravis
Session Date & Time: Poster Session
1, Sunday, April 23, 8-9 am ET
Presenter: Dr. George Li
Abstract Number: P1.5-017
Title: Overview of the Safety Profile
from Efgartigimod Clinical Trials in Participants with Diverse IgG-Mediated Autoimmune Diseases
Session Date & Time: Poster Session
1, Sunday, April 23, 8-9 am ET
Presenter: Dr. Kelly Gwathmey
Abstract Number: P1.5-001
Title: Efgartigimod Demonstrates Consistent
Improvements in Generalized Myasthenia Gravis Patients of Shorter Disease Duration
Session Date & Time: Poster Session
1, Sunday, April 23, 8-9 am ET
Presenter: Dr. Vera Bril
Abstract Number: P1.5-015
Title: Patient Support Program Enhancements
In Patients Diagnosed With Generalized Myasthenia Gravis Facing Social Determinants of Health Challenges
Session Date & Time: Poster Session
4, Monday, April 24, 8-9 am ET
Presenter: Dr. Tom Hughes
Abstract Number: P4.9-006
See the full Prescribing Information for VYVGART
in the U.S., which includes the below Important Safety Information. For more information related to VYVGART in Japan, visit argenx.jp.
Important Safety Information for VYVGART
(efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. prescribing information)
What is VYVGART (efgartigimod
VYVGART is a prescription medicine used to treat
a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are
positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
What is the most important information I should
VYVGART may cause serious side effects, including:
| Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. | ||
| Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions. |
Before taking VYVGART, tell your health care provider
about all of your medical conditions, including if you:
| Have a history of infection or you think you have an infection. | ||
| Have received or are scheduled to receive a vaccine (immunization). Discuss with your health care provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART. The use of vaccines during VYVGART treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART. | ||
| Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed. |
Tell your health care provider about all the medicines
you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART?
The most common side effects of VYVGART are respiratory
tract infection, headache, and urinary tract infection.
These are not all the possible side effects of
VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at
Please see the full Prescribing Information for
VYVGART and talk to your doctor.
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, where muscles throughout the body
may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.
About VYVGART (efgartigimod
VYVGART is a human IgG1 antibody fragment that
binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first
and only approved FcRn blocker. VYVGART is approved in the United States and Europe 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). VYVGART is being studied in adults with primary
immune thrombocytopenia (ITP) and other IgG autoantibody-mediated diseases.