Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) / argenx, ZAI Lab - LARVOL DELTA

Real-World Experience with FcRn Inhibitors Efgartigimod and Rozanolixizumab in Myasthenia Gravis: Administration in Multiple Cycles and Transition from Intravenous to Subcutaneous Formulation. (PubMed, Neurol Ther) - "FcRn inhibitors were effective and safe in patients with generalized MG, but their efficacy may depend on the disease activity during treatment. The transition from the intravenous formulation to more convenient subcutaneous formulations was successful, indicating the likely growth of future demand for subcutaneous formulations."

Journal • Real-world evidence • CNS Disorders • Myasthenia Gravis • Solid Tumor • Thymoma • Thymus Cancer

Halozyme Announces FDA Approval of argenx's VYVGART Hytrulo Prefilled Syringe Co-Formulated with ENHANZE for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy (PRNewswire) - "Halozyme Therapeutics...announced that argenx has received U.S. Food and Drug Administration (FDA) approval of VYVGART Hytrulo prefilled syringe for self-injection (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional....The approval of VYVGART Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART Hytrulo in a vial."

FDA approval • Immunology • Inflammation • Myasthenia Gravis

VYVGART Hytrulo Delivers Long-term Functional Improvements and Favorable Safety Profile for Patients with CIDP (GlobeNewswire) - P2 | N=229 | ADHERE+ (NCT04280718) | Sponsor: argenx | "ADHERE+ data demonstrate VYVGART Hytrulo delivers long-term clinical efficacy. Study results report functional improvements across aINCAT disability scores (>1-point), grip strength (>17 kPa) and I-RODS scale (>8 points) at week 36 compared to baseline at entry to standard of care withdrawal phase. In addition, the majority of ADHERE patients who relapsed during randomized treatment withdrawal stage, restabilized on VYVGART – 50% as early as week 4. Treatment-emergent adverse events (TEAEs) were consistent with label and no new events, nor increased rate or severity of TEAEs were reported with longer treatment with VYVGART Hytrulo."

P2 data • Pain

Consistent efficacy and safety results over nine treatment cycles (GlobeNewswire) - P3 | N=184 | ADAPTSC+ (NCT04818671) | Sponsor: argenx | "Interim results of ADAPT-SC+ demonstrate consistent and repeatable improvements in MG-ADL and MG Quality of Life (MG-QoL) scores in gMG patients treated with VYVGART Hytrulo. There was no observed increase in infections or injection-site reactions over nine cycles of treatment. Also, the proportion of patients able to achieve MSE was consistent across multiple cycles."

P3 data • Myasthenia Gravis

ADAPT-EARLY: A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: argenx

New P4 trial • CNS Disorders • Myasthenia Gravis

Efficacy and safety of efgartigimod PH20 subcutaneous by prefilled syringe in adults with primary Sjögren's disease: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial with open-label extension (UNITY) (EULAR 2025) - No abstract available

Clinical • P3 data • Sjogren's Syndrome

Efficacy and safety of efgartigimod PH20 SC in adult participants with active idiopathic inflammatory myopathy: Phase 2 results from the ALKIVIA study (EULAR 2025) - No abstract available

Clinical • P2 data • Myositis

Assessing VYVGART Social Media Data in Generalized Myasthenia Gravis To Understand Patient, Caregiver, and HCP Sentiment (ISPOR 2025) - "The number of online VYVGART posts grew significantly over the study timeframe, with patients highlighting improved QOL and access challenges, caregivers expressing improved patient performance of activities of daily living and access challenges, and HCPs sentiment was largely neutral."

Clinical • CNS Disorders • Myasthenia Gravis

Study on the therapeutic effects of subcutaneous efgartigimod formulation for myasthenia gravis crisis (JSNE 2025) - No abstract available

CNS Disorders • Myasthenia Gravis

Experience with subcutaneous injection of efgartigimod in patients with anti-AchR antibody-positive myasthenia gravis (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Myasthenia Gravis

Long-term efficacy of subcutaneous efgartigimod in patients with CIDP: interim report of the ADHERE+ trial (JSNE 2025) - No abstract available

Clinical

ADHERE study: Efficacy and safety of subcutaneous efgartigimod in patients with CIDP in East Asia (JSNE 2025) - No abstract available

Clinical

Evaluating pharmacist preferences: Preparation of a novel on-body delivery system vs. high-resistance, manual syringes for large-volume subcutaneous drugs. (PubMed, J Oncol Pharm Pract) - "BackgroundAlthough syringe preparation for large-volume (>3 mL) subcutaneous (SC) drugs represents a significant workflow burden for pharmacists, their preferences for alternatives such as on-body delivery systems (OBDSs) are unexplored.ObjectiveTo evaluate pharmacists' preferences for preparing OBDSs vs. syringes.MethodsIn this cross-sectional study, pharmacists in US academic or community settings with experience preparing SC daratumumab/hyaluronidase (HYAL), rituximab/HYAL, pertuzumab/trastuzumab/HYAL, and/or efgartigimod/HYAL completed a double-blinded, 21-item, online survey that included questions about preferences regarding the preparation of prefilled syringes versus an OBDS.ResultsThirty pharmacists completed the survey. 29 pharmacists (96.67%) felt that the OBDS would reduce burden, 30 (100%) felt that it would improve efficiency, and 27 (90%) felt that it would reduce preparation errors. 22 pharmacists (73.33%) felt that the OBDS could provide..."

Journal

COVID-19 Vaccination Response in Participants Across Clinical Trials Investigating Efgartigimod PH20 SC (AAN 2025) - "Participants receiving efgartigimod PH20 SC were able to mount antigen-specific IgG responses to COVID-19 immunization."

Clinical • CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis • Novel Coronavirus Disease • Respiratory Diseases

Investigating the Pharmacodynamics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administration Using a Prefilled Syringe (AAN 2025) - "This study demonstrated that efgartigimod PH20 SC administered via PFS is bioequivalent to efgartigimod PH20 SC administered via V+S, which may provide an additional convenient treatment option for patients with gMG and CIDP."

PK/PD data • CNS Disorders • Myasthenia Gravis • Pain

Study Design of Subcutaneous Efgartigimod PH20 in Juvenile Generalized Myasthenia Gravis (AAN 2025) - P2/3 | "This study will use PK/PD modeling to confirm the appropriate efgartigimod PH20 SC dose and evaluate efficacy and safety for pediatric patients with gMG. Efgartigimod PH20 SC may provide additional flexibility for the treatment of pediatric patients with gMG."

CNS Disorders • Fatigue • Myasthenia Gravis • Pediatrics

Treatment Impact of Efgartigimod PH20 SC on I-RODS Daily Activity Assessment in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: Post Hoc Analysis of the Registrational ADHERE Study (AAN 2025) - P2 | "Participants who received efgartigimod PH20 SC in stage-B experienced improvements in I-RODS score from study enrollment to stage-B last assessment."

Clinical • Retrospective data • Pain

Transition from Intravenous Immunoglobulin to Efgartigimod PH20 SC in Participants with Chronic Inflammatory Demyelinating Polyneuropathy: A Phase 4 Study in Progress (AAN 2025) - P4 | "This study will evaluate an approach to transitioning from IVIg to efgartigimod PH20 SC 1 week after a last IVIg infusion in patients with CIDP."

P4 data • Cognitive Disorders • Pain

Long-term Safety and Efficacy of Subcutaneous Efgartigimod PH20 in Adult Participants with Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study (AAN 2025) - "Treatment with multiple cycles of efgartigimod PH20 SC was well tolerated and efficacious."

Clinical • CNS Disorders • Myasthenia Gravis

Budget Impact of Subcutaneous Immunoglobulin, Intravenous Immunoglobulin and Efgartigimod Alfa in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the United States (AAN 2025) - "This analysis suggests that the introduction of efgartigimod alfa is expected to result in substantially increased spending in the treatment of CIDP."

Clinical • HEOR • Immunology • Pain

Combined Analyses of Participants with Anti-Acetylcholine Receptor Seronegative Generalized Myasthenia Gravis Treated with Efgartigimod Across Clinical Studies (AAN 2025) - "Both efgartigimod IV and efgartigimod PH20 SC were well tolerated and led to clinically meaningful improvements in symptoms for participants with AChR-Ab- gMG."

Clinical • CNS Disorders • Myasthenia Gravis

Design of a Phase 3 Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia Gravis (AAN 2025) - P3 | "This is the first Phase 3 clinical trial evaluating the safety and efficacy of efgartigimod PH20 SC in patients with oMG that addresses the unmet need for treatment in oMG."

Clinical • P3 data • CNS Disorders • Myasthenia Gravis

Long-Term Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: Interim Results from the ADHERE+ Study (AAN 2025) - P2 | "Interim results from ADHERE+ indicate long-term effectiveness of efgartigimod PH20 SC in clinical outcomes in participants with CIDP."

Clinical • Pain

argenx Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual Meeting (GlobeNewswire) - "argenx SE...today 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."

Clinical data • Myasthenia Gravis

A Protocol for a Pilot Trial of Efgartigimod for the Treatment of Acute Optic Neuritis (PET-AON) (ACTRIMS Forum 2025) - P2 | "All patients will receive standard of care methylprednisolone 1000 mg IV daily for 3 days with oral taper, or equivalent. We are investigating acute efgartigimod administration for the treatment of acute incident MSON using a novel mechanism of action."

Clinical • CNS Disorders • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Rare Diseases