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argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease | ||
By: GlobeNewswire - 16 Apr 2024 | Back to overview list |
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ADHERE data show VYVGART® Hytrulo has potential to be first advancement for CIDP patients in 30 years Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART® treatment April 16, 2024 – 7:00am 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 data from its Phase 3 ADHERE trial evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) were presented for the first time to the medical community during the Clinical Trials Plenary Session at the American Academy of Neurology (AAN) Annual Meeting in Denver, CO. argenx also highlighted clinical trial and real-world data across seven posters and presentations that continue to reinforce VYVGART and VYVGART Hytrulo as a transformative treatment option for gMG patients. “Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The gMG and CIDP data presented at AAN reinforce that our pioneering approach to transforming autoimmunity is redefining what is possible for patients and their communities.” “Patients with CIDP face a number of diagnostic and treatment challenges” said Jeffrey Allen, M.D., Professor, Department of Neurology, University of Minnesota and Principal Investigator in the ADHERE trial. “The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden. These findings enhance our understanding of the role that IgG autoantibodies are likely to play in the disease, and open the door to new safe, effective and well-tolerated treatments that eliminate pathogenic IgGs.” ADHERE Plenary Session (PL5) Highlights Rapid, Deep and Clinically Meaningful, and Durable Functional Improvements in CIDP In the ADHERE study, a majority of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of rapid clinical improvement, and a reduced risk of relapse compared to those treated with placebo. As previously reported, ADHERE met its primary endpoint (p=0.000039) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. VYVGART Hytrulo was well-tolerated, and the observed safety and tolerability profile was consistent with previous clinical trials.
AAN presentations highlight rapid, deep, and sustained improvements in gMG with ability to reduce steroid burden Clinical trial data and real-world evidence presented during AAN continue to highlight the differentiated efficacy and safety profile of VYVGART and VYVGART Hytrulo, driving rapid, deep, and sustained improvement across disease scales and with different dosing schedules, including the ability for patients to achieve minimal symptom expression (MSE).
Side effects from long-term steroid use continue to be a significant burden associated with autoimmune disease, reinforcing the importance of the favorable safety profile of VYVGART. New data presented in an oral presentation (Scientific Platform Session 38) during AAN characterize how VVYGART treatment can significantly reduce concomitant steroid use.
About ADHERE Trial Design 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 injection? IMPORTANT SAFETY INFORMATION VYVGART and VYVGART HYTRULO may cause serious side effects, including: Infection Allergic Reactions (hypersensitivity reactions) Infusion-Related Reactions 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 your doctor if you:
What are the common side effects of VYVGART and VYVGART HYTRULO? 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. Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO. About Generalized Myasthenia Gravis About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) About VYVGART® About VYVGART® Hytrulo 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 Contacts Media: Investors: Lynn Elton (EU) 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-looking terminology, including the terms “aims,” “committed,” “expects,” “may,” “will,” “potential,” "likely," or and include statements argenx makes concerning the potential impact of VYVGART and VYVGART Hytrulo for CIDP patients; its pioneering approach to transforming autoimmunity redefining what is possible for patients and their communities; the role IgG autoantibodies are likely to play in the disease, and new safe, effective and well-tolerated treatments that eliminate pathogenic IgGs; and the expected FDA's decision of CIDP sBLA. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials, expectations regarding the inherent uncertainties associated with development of novel drug therapies, preclinical and clinical trial and product development activities and regulatory approval requirements, the acceptance of argenx's products and product candidates by its patients as safe, effective and cost-effective, the impact of governmental laws and regulations on its business, and the results of its PDUFA review. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most 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-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. |
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