お知らせ • Mar 08
Argenx Highlights FcRn Leadership with Long-Term Data and Transformational Patient Outcomes At the American Academy of Neurology 2025 Annual Meeting
On March 7, 2025, argenx SE announced clinical trial and real-world data for VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in San Diego, CA from April 5-9, 2025. Abstracts at AAN will highlight real-world and clinical data demonstrating VYVGART’s sustained clinical improvements, including consistent functional improvement and a favorable safety profile. In addition, presentations support an individualized treatment approach and the ambition for VYVGART to reach patients earlier in the treatment paradigm. Additional dosing approaches achieve clinical improvements in gMG through 126 weeks: New data from ADAPT-NXT, investigating biweekly or every three-week dosing of VYVGART, demonstrated sustained clinical improvements, including minimal symptom expression (MSE), and consistent long-term safety through 126 weeks. · Largest long-term data set of any FcRn blocker in gMG shows sustained safety and efficacy: ADAPT-SC+ analyses of VYVGART Hytrulo demonstrate consistent safety results and sustained efficacy through nine cycles of treatment. · Favorable benefit-risk profile in gMG: A comparative effectiveness study of emerging immunomodulatory therapies for patients with gMG shows that Fc receptor blockers, particularly VYVGART, show a more favorable benefit-risk profile. · Long-term effectiveness in CIDP: Interim results from the open-label extension ADHERE+ further build upon the largest clinical data set supporting long-term efficacy, including functional improvement and safety of VYVGART Hytrulo in CIDP. · Switch from IVIg to efgartigimod in CIDP: The Phase 4 open-label trial is investigating effective and safe transition from stable IVIg doses to VYVGART Hytrulo within one week after last IVIg dose. 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). Do not use VYVGART if user have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART may cause serious side effects, including: · Infection.VYVGART may increase the risk of infection. The most common infections 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 can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART. · Infusion-Related Reactions.VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Telluser’sdoctor ifuserhave signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen whileuserare receivinguser’sVYVGART treatment or afterward.user’sdoctor may need to pause or stopuser’streatment. Contactuser’sdoctor immediately ifuserhave signs or symptoms of a serious allergic reaction. Before taking VYVGART, telluser’sdoctor 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 ifuserare pregnant or planning to become pregnant, or are breastfeeding. 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. Calluser’sdoctor for medical advice about side effects.usermay report side effects to the US Food and Drug Administration at 1-800-FDA-1088. VYVGART HYTRULO 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). VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) Do not use VYVGART HYTRULO ifuserhave 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. 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.