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argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting ADHERE data presentation will highlight first potential innovation for CIDP patients in 30

Key Takeaway: argenx SE announced that it will present eight abstracts at the American Academy of Neurology 2024 Annual Meeting, including oral presentations of VYVGART and VYVGART Hytrulo data. The data showcase the potential of these treatments to provide significant benefits to patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a community that has seen no innovation for three decades. The findings will further detail the efficacy, safety, and long-term use of these therapies. A PDUFA target action date of June 21, 2024, has been set for the potential FDA approval of VYVGART Hytrulo in CIDP.

Market Sentiment Analysis

POSITIVE FACTORS

  • First potential innovation for CIDP patients in 30 years.
  • Positive data from the ADHERE study submitted for FDA approval.
  • VYVGART demonstrates consistent efficacy and safety profile.
  • Broad dataset presented at the American Academy of Neurology.

Full Press Release Details

argenx Delivers on Promise to Transform Patient
Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting
ADHERE data presentation will highlight first
potential innovation for CIDP patients in 30 years
reflect real-world value and consistent efficacy and safety profile associated with long-term use of VYVGART
and VYVGART Hytrulo in gMG patients
March 7, 2024, 10:01 pm CET
the Netherlands - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives
of people suffering from severe autoimmune diseases, today announced that eight abstracts, including two oral presentations, featuring
clinical trial and real-world data for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
in rare autoimmune diseases will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, CO from
"We are opening a new chapter for the VYVGART
portfolio," said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "While VYVGART continues to reach more gMG patients
globally, we are also striving to bring meaningful benefits to people living with CIDP - a community which has been awaiting innovation
for 30 years. We are excited to present a broad set of data at AAN this year that collectively demonstrate how we are delivering on our
promise to transform patients' lives with innovative treatments."
Transforming Autoimmunity by Targeting FcRn
Findings from the ADHERE study of VYVGART Hytrulo
in chronic inflammatory demyelinating polyneuropathy (CIDP) will be presented for the first time in an oral presentation during the Clinical
Trials Plenary Session, taking place on Tuesday, April 16, 2024. These positive data from the ADHERE study have been submitted to the
FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
In addition to the full ADHERE data, the AAN presentations
will highlight clinical trial and real-world data showcasing the broad opportunity with VYVGART, a first-in-class neonatal FC receptor
(FcRn) inhibitor, and VYVGART Hytrulo, to deliver significant value to the generalized myasthenia gravis (gMG) patient community by driving
consistent and repeatable improvements across patient subtypes, a favorable and predictable safety profile, and the ability to individualize
treatment across both intravenous and subcutaneous administration and dosing schedules.
Details for oral and poster presentations at
Title Lead Author Presentation
Efficacy, Safety, and Tolerability of Efgartigimod in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: Results From the ADHERE Trial Jeffrey Allen Oral Presentation during Clinical Trial Plenary Session Tuesday, April 16, 9:15-11:30 a.m. MT
Real-world Reduction in Oral Corticosteroid Utilization following Efgartigimod Initiation in Patients Living with Generalized Myasthenia Gravis Neelam Goyal Oral Presentation Wednesday, April 17 3:42 p.m. MT
Cost-effectiveness Analysis of Efgartigimod versus Chronic Intravenous Immunoglobulin (IVIg) for Treatment of Acetylcholine Receptor Antibody Positive (AChR-Ab+) Generalized Myasthenia Gravis (gMG) in Canada Zaeem Siddiqi Poster Presentation Monday, April 15 11:45 a.m.-12:45 p.m. MT
Overview of the Safety Profile from Efgartigimod Clinical Trials in Participants with Diverse IgG-mediated Autoimmune Diseases Tuan Vu Poster Presentation Monday, April 15 11:45 a.m.-12:45 p.m. MT
Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study James Howard Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT
Fixed-Cycle and Continuous Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Study Design of ADAPT NXT Vera Bril Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT
Achievement of Minimal Symptom Expression and Effect on Disease-Specific Measures in Acetylcholine Receptor Antibody-Positive Participants With Generalized Myasthenia Gravis Treated With Efgartigimod in ADAPT/ADAPT+ Srikanth Muppidi Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT
Analysis of Serious Infections and Malignancy Risk in Myasthenia Gravis: a US Claims Database Study Jana Podhorna Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT
More information on the program is available at AAN.
See Important Safety Information below, full United
States Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information.
What is VYVGART (efgartigimod
alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous
VYVGART and VYVGART HYTRULO are both prescription
medicines, each 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).
Do not use VYVGART if you have a serious allergy
to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod
alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions
and a decrease in blood pressure leading to fainting
VYVGART and VYVGART HYTRULO may cause serious
side effects, including:
VYVGART and VYVGART HYTRULO may increase the risk
of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections.
Signs or symptoms of an infection may include 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.
Allergic Reactions (hypersensitivity reactions)
VYVGART and VYVGART HYTRULO can cause allergic
reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART
HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with
efgartigimod alfa-fcab.
Infusion-Related Reactions
VYVGART and VYVGART HYTRULO can cause infusion-related
reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and
chest, abdominal, and back pain
Tell your doctor if you have signs or symptoms
of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO
treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms
of a serious allergic reaction.
Before taking VYVGART or VYVGART HYTRULO, tell
What are the common side effects of VYVGART
and VYVGART HYTRULO?
The most common side effects in efgartigimod-alfa-fcab-treated
patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO
are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of
VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug
Administration at 1-800-FDA-1088.
see the full Prescribing Information for VYVGART and the full Prescribing
Information for VYVGART HYTRULO.
Generalized Myasthenia Gravis
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
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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.
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).
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.
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.
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
Forward-Looking Statements
contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking

Frequently Asked Questions

What is VYVGART used for?

VYVGART is a prescription medication for treating generalized myasthenia gravis in antibody-positive adults.

What are the common side effects of VYVGART?

Common side effects include respiratory tract infections, headaches, and urinary tract infections.

When will ADHERE study results be presented?

ADHERE study results will be presented on April 16, 2024, at the AAN Annual Meeting.

What is CIDP?

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a serious autoimmune disease affecting peripheral nerves.

What does argenx aim to achieve with VYVGART?

argenx aims to transform patient lives through innovative treatments for autoimmune diseases.

Last updated: Mar 7, 2024