6-K
Argenx SE (ARGX)
UNITED STATES
SECURITIES AND EXCHANGECOMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATEISSUER
PURSUANT TO RULE 13a-16OR 15d-16
UNDER THE SECURITIESEXCHANGE ACT OF 1934
For the Month of March 2023
Commission File Number:001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 251101 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 March 15, 2023, 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, is incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251)and S-8 (File Nos. 333-225375 and 333-258253).
| Exhibit | Description |
|---|---|
| 99.1 | Press Release dated<br> March 15, 2023 |
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.
| ARGENX SE | ||
|---|---|---|
| Date: March 15, 2023 | By: | /s/ Hemamalini<br> (Malini) Moorthy |
| Hemamalini (Malini) Moorthy |
Exhibit 99.1
argenx Announces UK MHRA Approval of VYVGARTfor the Treatment of Generalized Myasthenia Gravis
VYVGART is the firstneonatal Fc receptor (FcRn) blocker approved in the UK for the treatment of adults living with generalized myasthenia gravis (gMG) whoare anti-acetylcholine receptor (AChR) antibody positive
68% of anti-AChR antibodypositive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scalecompared with 30% of patients treated with placebo (n=19/64) (p<0.0001) during the first treatment cycle in the Phase 3 ADAPT trial
argenx is committed tocollaborating with local authorities to facilitate broad and rapid access to VYVGART for eligible patients
MARCH 15, 2023
Amsterdam, the Netherlands — 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%).
^1^ VYVGART UK Summary of Product Characteristics
^2^ Howard JF et al. Lancet Neurol 2021;20(7):526-536.
“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.
About Phase 3 ADAPT Trial
The Phase 3 ADAPT trial was a 26-week randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of efgartigimod in adult patients with gMG. A total of 167 adult patients with gMG in North America, Europe and Japan enrolled in the trial. Patients were randomized in a 1:1 ratio to receive efgartigimod or placebo, in addition to stable doses of their current gMG treatment. ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by subsequent treatment cycles based on clinical evaluation. The primary endpoint was the comparison of percentage of MG-ADL responders in the first treatment cycle between efgartigimod and placebo treatment groups in the anti-AChR antibody positive population^2^.
About VYVGART
VYVGART (efgartigimod alfa-fcab) 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, Europe and the UK 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 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^2^, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population^3^.
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-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., the EU, Japan and the UK.
^3^ Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
For further information, please contact:
Media:
Erin Murphy
Investors:
Beth DelGiacco
Forward-looking Statements
The contents of this announcement include statements that are,or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-lookingterminology, including the terms “believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerningthe commercialization of VYVGART^®^in the UK, the access of patients to VYVGART and the impact thereof on reducingthe burden of gMG. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any suchforward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predictedby the forward-looking statements as a result of various important factors. A further list and description of these risks, uncertaintiesand other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’smost recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC.Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-lookingstatements speak only as of the date of publication of this document. argenx undertakes no obligation publicly update or revise the informationin this press release, including any forward-looking statements, except as may be required by law.