UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of December 2024
Commission File Number: 001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
EXPLANATORY NOTE
On December 27, 2024, argenx SE (the “Company”)
issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information contained in this Current Report
on Form 6-K, including Exhibit 99.1, shall be deemed to be incorporated by reference into the Company’s Registration Statements
on Forms F-3 (File No. 333-258251) and S-8 (File Nos. 333-225375, 333-258253, and 333-274721), and to be part thereof from
the date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed
or furnished.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ARGENX SE |
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| Date: December 27, 2024 |
By: |
/s/ Hemamalini (Malini) Moorthy |
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Name: Hemamalini (Malini) Moorthy
Title: General Counsel |
Exhibit 99.1
argenx Announces Approval of VYVDURA (efgartigimod
alfa and hyaluronidase-qvfc) in Japan for Adults with Chronic Inflammatory Demyelinating Polyneuropathy
VYVDURA®
now approved for at-home self-injection in Japan for both generalized myasthenia gravis and CIDP
argenx's
VYVGART® and VYVDURA portfolio approved in Japan for three indications – first country globally
with access across three indications
December 27, 2024, 7:00 AM CET
Amsterdam,
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 Japan’s Ministry of Health, Labour and Welfare (MHLW)
approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVDURA is approved for CIDP as a once weekly
30-to-90 second subcutaneous injection, which can be self-administered at home, and is the first and only neonatal Fc receptor (FcRn)
blocker approved for the treatment of CIDP.
“CIDP is a rare and debilitating disease
for which there has been little innovation in treatment in 30 years,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
“With VYVDURA, CIDP patients in Japan now have access to a novel therapy with a focused mode of action offering a convenient 30-to-90
second at-home self-injection option with an established efficacy and safety profile, as demonstrated by the ADHERE trial and real-world
evidence. By extending the reach of this transformational therapy to thousands more patients, argenx continues to bring efgartigimod,
our first-in-class FcRn blocker, to more patients in Japan and around the world suffering from severe autoimmune disease.”
CIDP is a progressive, immune-mediated rare and
debilitating neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues,
including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. Many patients become wheelchair
bound and are unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated
patients experience residual impairment and disability.
The MHLW approval is based on the ADHERE Study,
the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVDURA, regardless of prior
treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary
endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. Ninety-nine
percent of trial participants elected to participate in the ADHERE+ open-label extension. The safety results were generally consistent
with the known safety profile of VYVDURA in previous clinical studies and real-world use.
VYVDURA was approved by the MHLW for manufacturing
and marketing in January 2024 and launched in April 2024 for the treatment of generalized myasthenia gravis (gMG). In March 2024,
VYVDURA was designated as an Orphan Drug for the treatment of CIDP by the MHLW.
See
FDA-approved Important Safety Information below and full Prescribing Information for VYVDURA, which is marketed as VYVGART
Hytrulo in the United States, for additional information.
What is VYVGART® HYTRULO (efgartigimod
alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used
for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
IMPORTANT SAFETY INFORMATION
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 HYTRULO can cause serious allergic
reactions and a decrease in blood pressure leading to fainting.
VYVGART HYTRULO may cause serious side effects,
including:
| · | Infection. 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 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 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 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 HYTRULO, tell your doctor
if you:
| · | take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, |
| · | have received or are scheduled to receive a vaccine (immunization), or |
| · | have any allergies or medical conditions, including if you are pregnant or planning to become pregnant,
or are breastfeeding. |
What are the common side effects of 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 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.
Please see the full Prescribing Information
for VYVGART HYTRULO and talk to your doctor.
About ADHERE Trial Design
The ADHERE trial was a multicenter, randomized,
double-blind, placebo-controlled trial evaluating VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment
of chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled 322 adult patients with CIDP who were treatment naïve
(not on active treatment within the past six months or newly diagnosed) or being treated with immunoglobulin therapy or corticosteroids.
The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial,
the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment
was stopped and in order to be eligible for Stage A had to demonstrate active disease, with clinically meaningful worsening on at least
one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment naïve patients were able to skip
the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement
(ECI) with VYVDURA. ECI was achieved through improvement of the INCAT score, or improvement on I-RODS or mean grip strength if those
scales had demonstrated worsening during the run-in period. In Stage B, patients were randomized to either VYVDURA or placebo for up
to 48 weeks. The primary endpoint was measured once 88 total relapses or events were achieved in Stage B and was based on the hazard
ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an
open-label extension study to receive VYVDURA.
About VYVDURA
VYVDURA 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), VYVDURA results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered
by subcutaneous injection for the treatment of CIDP.
VYVDURA is the proprietary name in Japan for subcutaneous
efgartigimod alfa and recombinant human hyaluronidase PH20. It is marketed under different proprietary names in other regions.
About Chronic Inflammatory Demyelinating Polyneuropathy
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 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.
Contacts
Media:
Ben Petok
Bpetok@argenx.com
Investors:
Alexandra
Roy (US)
aroy@argenx.com
Lynn Elton
(EU)
lelton@argenx.com
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