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

argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (argenx Press Release) - "argenx SE...announced that the European Commission (EC) approved VYVGART (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation....The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date."

EMA approval • Immunology

SAFETY PROFILE OF SUBCUTANEOUS EFGARTIGIMOD PH20 FROM CLINICAL TRIALS IN MYASTHENIA GRAVIS AND CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (EULAR 2025) - P2, P3 | "Efgartigimod PH20 SC was well-tolerated across indications and dosing regimens. Most TEAEs were mild to moderate in severity and did not increase in frequency with recurrent dosing."

Clinical • CNS Disorders • Infectious Disease • Myasthenia Gravis • Pain

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) - P3 | "This phase 3 study with OLE will evaluate efgartigimod PH20 SC versus placebo in adult participants with clinESSDAI ≥6 (moderate-to-severe pSjD)."

Clinical • P3 data • Developmental Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology • 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) - P2/3 | "ALKIVIA is the first study of an FcRn inhibitor in IIM, establishing proof of concept. Efgartigimod PH20 SC led to significant improvement over placebo in TIS and key secondary endpoints with good safety and tolerability. The results demonstrate the mechanistic relevance of FcRn inhibition in IIM, indicating the potential pathogenicity of autoantibodies in IIM."

Clinical • P2 data • Dermatology • Dermatomyositis • Myositis • Rare Diseases • Rheumatology

argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis… (GlobeNewswire) - P2/3 | N=240 | ALKIVIA (NCT05523167) | Sponsor: argenx | "argenx SE...announced the presentation of positive results from Phase 2 studies evaluating VYVGART...in...idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025.....In the ongoing, seamless ALKIVIA Phase 2/3 study evaluating three myositis subtypes (IMNM, ASyS, DM), data from Phase 2 show that patients demonstrated significant improvement in muscle strength and physical function when treated with efgartigimod....TIS improvement was observed in a majority of efgartigimod-treated patients across all six core measures, and the primary endpoint was met. Efgartigimod patients showed a significantly higher mean TIS of 50.45 compared to 35.65 in the placebo arm (2-sided P=0.0004). In addition, for patients treated with efgartigimod, 79% achieved a moderate improvement (TIS ≥40) and 34% achieved a major improvement (TIS ≥60)..."

P2 data • Myositis

Changes in intravenous or subcutaneous immunoglobulin usage before and after efgartigimod initiation in patients with Myasthenia Gravis (CNSF 2025) - No abstract available

Clinical • CNS Disorders • Myasthenia Gravis

Investigating the bioequivalence, injection speed, and usability of subcutaneous efgartigimod PH20 administration using a prefilled syringe (CNSF 2025) - No abstract available

CNS Disorders

Long-term efficacy of Efgartigimod PH20 SC in patients with chronic inflammatory demyelinating polyneuropathy: interim results from the ADHERE+ study (CNSF 2025) - No abstract available

Clinical • CNS Disorders • Pain

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 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

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

Clinical 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

argenx Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Efgartigimod Development...Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027."

P2 data • Immunology • Lupus Nephritis • Systemic Sclerosis

Expand the global VYVGART opportunity and launch VYVGART SC as a pre-filled syringe (GlobeNewswire) - "Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $790 million in the first quarter of 2025: Strong underlying fundamentals across key patient and prescriber metrics with 99% product net sales growth year-over-year from first quarter 2024, and 7% product net sales growth from fourth quarter 2024....Topline results from Phase 4 switch study to inform treatment decisions when switching patients on IVIg to VYVGART SC in CIDP expected in second half of 2025 and to be presented at an upcoming medical meeting."

P4 data • Sales • Immune Thrombocytopenic Purpura • Immunology • Myasthenia Gravis

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

Clinical

Zai Lab Announces First Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "Product revenue, net was $105.7 million in the first quarter of 2025, compared to $87.1 million for the same period in 2024, representing 21% y-o-y growth, 23% y-o-y growth at constant exchange rate (CER). This increase was primarily driven by increased sales for VYVGART, ZEJULA, and NUZYRA....VYVGART and VYVGART Hytrulo were $18.1 million in the first quarter of 2025, compared to $13.2 million for the same period in 2024....ZEJULA was $49.5 million in the first quarter of 2025, compared to $45.5 million for the same period in 2024. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China. NUZYRA was $15.1 million in the first quarter of 2025, compared to $9.9 million for the same period in 2024. This growth was supported by increasing market coverage and penetration."

Commercial • Infectious Disease • Myasthenia Gravis • Ovarian Cancer

ADHERE Study: Efficacy and Safety of Subcutaneous Efgartigimod in East Asian Patients with CIDP (JSNE 2025) - No abstract available

Clinical

The therapeutic effect of subcutaneous injection of efgartigimod on myasthenia gravis crisis (JSNE 2025) - No abstract available

CNS Disorders • Myasthenia Gravis

Safety profile of efgartigimod from global clinical trials across multiple immunoglobulin G-mediated autoimmune diseases. (PubMed, Expert Rev Clin Immunol) - "Efgartigimod did not reduce albumin or increase LDL cholesterol levels. Across clinical trials in IgG-mediated autoimmune diseases, efgartigimod was well tolerated with similar safety profiles regardless of dosing regimen."

Journal • Immunology • Infectious Disease

argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (GlobeNewswire) - "argenx SE...announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission (EC) approval of VYVGART 1000mg (efgartigimod alfa) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins...The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date."

CHMP • Inflammation

BALLAD+: A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (clinicaltrials.gov) - P3 | N=64 | Terminated | Sponsor: argenx | N=160 ➔ 64 | Trial completion date: Mar 2026 ➔ Mar 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Mar 2025; Sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology

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