Hyaluronidase

ADHERE data presentation will highlight first potential innovation for CIDP patients in 30 years Abstracts reflect real-world value and consistent efficacy and safety pro with long-term use of VYVGART® and VYVGART® Hytrulo in gMG patients March 7, 2024, 10:01 pm 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 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 April 13-18, 2024. “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. Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies. Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment. Favorable safety pro IgG-mediated autoimmune diseases: A review of safety findings across multiple studies of VYVGART in IgG-mediated autoimmune diseases showed VYVGART was consistently well tolerated across all indications and doses studied. ADAPT NXT evaluated additional individualized dosing regimens for initiating long-term treatment: Data from the Phase 3b ADAPT NXT study will provide important guidance on different treatment regimens, which will allow for additional individualization of VYVGART treatment. Potential for tapering of oral corticosteroids (OCS) post-VYVGART initiation: Long-term OCS use continues to be a significant burden on people living with autoimmune disease and reducing or tapering OCS may alleviate the risk of many adverse events related to long-term usage. Early insights into OCS utilization post-efgartigimod initiation in gMG patients indicate that a substantial proportion reduced OCS usage over the first 6 months of treatment. Cost-effectiveness of VYVGART compared to chronic intravenous immunoglobulin (IVIg): Findings from a cost-effectiveness analysis of VYVGART versus chronic IVIg for the treatment of gMG showed that, over a lifetime, VYVGART provided greater benefit at lowers costs. Details for oral and poster presentations at AAN are as follows: 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 Pro 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 injection? 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). IMPORTANT SAFETY INFORMATION 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: Infection 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 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 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. Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO. 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,1 where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.1 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 VYVGART® VYVGART 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). About VYVGART® Hytrulo VYVGART 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. 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 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 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 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,” “strive” or “anticipate” and include statements argenx makes concerning the potential impact of VYVGART and VYVGART Hytrulo for CIDP patients; its promise to transform patients’ lives with innovative treatments; the opportunity with VYVGART and VYVGART Hytrulo to deliver significant value to the gMG patient community by driving consistent and repeatable improvements; its expectation that VYVGART and VYVGART Hytrulo reduce maternal IgG antibody levels, thereby reducing the passive protection to the newborn; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. 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 our products and product candidates by our patients as safe, effective and cost-effective, and the impact of governmental laws and regulations on our business. 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.

THE FIRST AND ONLY HYALURONIC ACID DERMAL FILLER APPROVED FOR THE IMPROVEMENT OF MODERATE TO SEVERE TEMPLE HOLLOWING1 IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.*1 "The approval of JUVÉDERM® VOLUMA® XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie. "This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients." JUVÉDERM® VOLUMA® XC temporarily adds volume to immediately lift and augment the shape, contour, and structure of the temple, creating a smooth transition from the cheekbone to the forehead, balancing a patient's overall facial shape.1 In a clinical study, more than 80% of subjects had at least a one-point improvement in moderate to severe temple hollowing three months after treatment, and the improvement lasted for more than one year (73%).1 Additionally, more than 85% of clinical trial subjects were satisfied with how balanced, well-proportioned, and symmetric their face looked three months after treatment.1 In the clinical study, 68% of subjects reported satisfaction with how fresh their face looked, while 73% reported satisfaction with how rested their face appeared three months after treatment.1 Additionally, upwards of 80% of subjects were satisfied with how youthful their temples made them look and how well the shape of their temples complemented the shape of their face three months after treatment.1 With this addition, the Allergan Medical Institute (AMI) team can train aesthetic providers on safe and effective treatments using the Allergan Aesthetics portfolio to address 90% of the face. "As an AMI trainer, I am excited to start training injectors on how to use JUVÉDERM® VOLUMA® XC to help address moderate to severe temple hollowing while reinforcing how treatment in this important area fits into a full-face approach that enhances facial balance (framing) and contour for my patients seeking subtle improvement," said Dr. Deirdre Hooper, board-certified dermatologist at Audubon Dermatology, and clinical trial investigator. "In the clinical study, we found that patients said they looked an average of five years younger six months after JUVÉDERM® VOLUMA® XC treatment.1 Additionally, more than 85% of clinical study participants were satisfied with the treatment and would recommend it to a friend more than one year after treatment.1 Once training is completed, injectors like me will be able to offer patients true pan-facial assessments and treatments for safe, repeatable, and optimal results using the Allergan Aesthetics portfolio of products." Per FDA requirement for this new indication, Allergan Aesthetics is providing a product training program for providers, which includes facial anatomy and considerations for patient selection, safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to the administration of JUVÉDERM® VOLUMA® XC, and as such, Allergan Aesthetics anticipates that treatment in the temples with JUVÉDERM® VOLUMA® XC will be available towards the end of this year. In a randomized, controlled, multicenter clinical study to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® XC for correction of temple hollowing, 112 subjects were randomized to a treatment group and received injections in the temple area during the primary phase of the study; 58 subjects were randomized to a no-treatment control group.1 Touch-up treatments occurred approximately 30 days after initial injection, if needed.1 After the three-month blinded "no treatment" control period, control subjects were offered treatment; 53 control subjects elected to receive treatment.2 A total of 40 treatment-group subjects opted for the optional maintenance treatment, which was offered to the treatment group 13 months after the last treatment.2 Subjects used electronic diaries to record specific signs and symptoms of treatment site responses (TSR) experienced during the first 14 days after the initial touch-up and maintenance treatments.2 Subjects in the initial treatment group continued to use the electronic diary on even-numbered days from day 16 to day 30 to record specific signs and symptoms of TSRs.2 Subjects rated each TSR listed on the diary as "Mild (barely noticeable)," "Moderate (uncomfortable)," "Severe (severe discomfort)," or "None."2 After initial treatment with JUVÉDERM® VOLUMA® XC, 59% of the subjects with diary entries reported experiencing at least one TSR and 70.5% of subjects rated TSRs as mild or moderate (26.3%) in severity, with a majority (60%) of all reported TSRs resolving within three days.2 The incidence of TSRs for the touch-up and maintenance treatments was lower than that for initial treatment.2 JUVÉDERM® VOLUMA® XC, one of six specifically designed products in the JUVÉDERM® Collection of Fillers, is currently also indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume loss in the mid-face, and for augmentation of the chin region to improve the chin profile.3,4 To learn more about the JUVÉDERM® Collection of Fillers, visit and follow @JUVEDERM on social media. For aesthetic providers interested in learning more about injection training, please speak to your Allergan Aesthetics Business Development Manager. *Some patients may require a touch-up treatment to achieve desired result. JUVÉDERM® VOLUMA® XC Injectable Gel Important Information APPROVED USES JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss, for augmentation of the chin region to improve the chin profile, and for augmentation of the temple region to improve moderate to severe temple hollowing in adults over 21. IMPORTANT SAFETY INFORMATION Are there any reasons why I should not receive any JUVÉDERM® formulation? Do not use if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers. What warnings should my doctor advise me about? One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately. The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed until healing is complete, as these could delay healing or make your skin problems worse. The effectiveness of removal of any dermal filler has not been studied. What precautions should my doctor advise me about? Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, under 22 years or over 80 years for chin augmentation, and under 32 years or over 82 years for temple area augmentation The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® VOLUMA® XC in patients with a history of excessive scarring or pigmentation disorders has not been studied. Use in these patients may result in additional scars or changes in pigmentation Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for What are possible side effects? The most common reported side effects were tenderness, firmness, swelling, lumps/bumps, pain, bruising, redness, discoloration, and itching. The majority were mild or moderate in severity across all studies and resolved within 2 to 4 weeks. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid). As with all skin injection procedures, there is a risk of infection. To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1‑877‑345‑5372. Please also visit Juvederm.com or talk to your doctor for more information. Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. References JUVÉDERM® VOLUMA® XC Patient Labeling for Temple. 2024. JUVÉDERM® VOLUMA® XC Directions for Use. 2024. JUVÉDERM® VOLUMA® XC Patient Labeling for Cheek. 2019. JUVÉDERM® VOLUMA® XC Patient Labeling for Chin. 2020. SOURCE AbbVie