HyQvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase) / Halozyme, Takeda - LARVOL DELTA

Tolerability of immunoglobulin products and outcomes after product switching: a single-center real-world retrospective study. (PubMed, Front Immunol) - "Among the seven patients treated with facilitated SCIG (SC HyQvia®), three experienced ADRs, and one of them was switched back to conventional SCIG (SC Hizentra®) due to persistent local adverse reactions, with no further ADRs reported after the switch. ADRs associated with IVIG are common and lead to treatment switching in a high proportion of patients. Switching to an alternative immunoglobulin product appears to be a good alternative for managing ADRs."

Journal • Observational data • Real-world evidence • Retrospective data

Successful treatment of necrobiotic xanthogranuloma with subcutaneous immunoglobulin and topical roxulitinib. (PubMed, JAAD Case Rep) - No abstract available

Journal • Langerhans Cell Histiocytosis • Monoclonal Gammopathy

TAK-771-3002: A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) (clinicaltrials.gov) - P3 | N=26 | Completed | Sponsor: Takeda | Trial primary completion date: Mar 2024 ➔ Oct 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial primary completion date • Complement-mediated Rare Disorders

Transition to SCIG as an Alternative in Patients with Cytokine Storm from IVIG (EAACI 2026) - "Materials and A 58-year-old man with CVID associated with protein-losing enteropathy had been treated with weight-adjusted IVIG (Flebogamma®, 45 g every 21 days) since 2015, with persistently low IgG levels...Transition to SCIG with recombinant hyaluronidase (HyQvia®) was decided in June 2025...All doses were administered with oral premedication 1 hour before each infusion: paracetamol 1 g, montelukast 10 mg, famotidine 40 mg, and bilastine 20 mg... We report a case of SCIG challenge in a patient with a previous diagnosis of moderate cytokine storm related to IVIG. Subcutaneous administration, especially when introduced through a progressive and stepwise schedule, is characterized by slow and controlled absorption that prevents systemic peaks and abrupt immune activation, thereby hindering the development of cytokine storm. In patients who have experienced cytokine storm with IVIG, gradual transition to the subcutaneous route is a safe alternative that..."

Clinical • Cytokine storm • Immunology • Primary Immunodeficiency • IL6

Transition to SCIG as an Alternative in Patients with Cytokine Storm from IVIG (EAACI 2026) - "Materials and A 58-year-old man with CVID associated with protein-losing enteropathy had been treated with weight-adjusted IVIG (Flebogamma®, 45 g every 21 days) since 2015, with persistently low IgG levels...Transition to SCIG with recombinant hyaluronidase (HyQvia®) was decided in June 2025...All doses were administered with oral premedication 1 hour before each infusion: paracetamol 1 g, montelukast 10 mg, famotidine 40 mg, and bilastine 20 mg... We report a case of SCIG challenge in a patient with a previous diagnosis of moderate cytokine storm related to IVIG. Subcutaneous administration, especially when introduced through a progressive and stepwise schedule, is characterized by slow and controlled absorption that prevents systemic peaks and abrupt immune activation, thereby hindering the development of cytokine storm. In patients who have experienced cytokine storm with IVIG, gradual transition to the subcutaneous route is a safe alternative that..."

Clinical • Cytokine storm • Immunology • Primary Immunodeficiency • IL6

Pharmacokinetics, safety and tolerability, and efficacy of hyaluronidase-facilitated subcutaneous immunoglobulin 10% (HyQvia®) in Japanese patients with primary immunodeficiency diseases. (PubMed, Immunol Med) - P3 | "Prior treatments included cSCIG (62.5%), IVIG (31.3%), and SCIG (human) 20% solution (Ig20Gly; Cuvitru®) (6.3%). No TEAEs led to study discontinuation. fSCIG 10% effectively maintained IgG levels, prevented infections, and was well tolerated in Japanese patients with PID transitioning from IVIG or cSCIG."

Journal • PK/PD data • Immunology • Infectious Disease • Primary Immunodeficiency

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P2/3 | N=65 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Jan 2026

Adverse events • Trial completion • Trial completion date • Immunology • Primary Immunodeficiency

TAK-771-3002: A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) (clinicaltrials.gov) - P3 | N=26 | Active, not recruiting | Sponsor: Takeda | Trial completion date: Oct 2025 ➔ May 2026

Trial completion date • Complement-mediated Rare Disorders • Pain

A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants (clinicaltrials.gov) - P3 | N=15 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Immunology • Primary Immunodeficiency

A Study of TAK-881 and HyQvia in Healthy Adults (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Takeda | Recruiting ➔ Completed

Trial completion

TAK-771-3002: A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) (clinicaltrials.gov) - P3 | N=26 | Active, not recruiting | Sponsor: Takeda | Trial completion date: Jun 2025 ➔ Oct 2025

Trial completion date • Complement-mediated Rare Disorders • Pain

TAK-881-3003: A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=59 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

HYbISCUE: A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Pain

A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants (clinicaltrials.gov) - P3 | N=15 | Active, not recruiting | Sponsor: Takeda | Trial completion date: Apr 2025 ➔ Oct 2025 | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

A Study of TAK-881 and HyQvia in Healthy Adults (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P2/3 | N=65 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Immunology • Primary Immunodeficiency

A Study of TAK-881 and HyQvia in Healthy Adults (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Takeda

New P1 trial

Héma-Québec to Reimburse HyQvia for the Treatment of Immunodeficiencies in Adult and Pediatric Patients Over 2 Years of Age (Canada Newswire) - "Takeda Canada Inc...is pleased to announce that Héma-Québec has added HyQvia (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immunodeficiency (PI) or secondary humoral immunodeficiency (SI) – to its list of plasma products distributed in Quebec. The treatment will now be reimbursed for adult and pediatric patients two years of age and older starting January 30, 2025."

Reimbursement • Immunology • Primary Immunodeficiency

Halozyme Announces Takeda Received Regulatory Approval for HYQVIA 10% Subcutaneous Injection Set with ENHANZE in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia (PRNewswire) - "Halozyme Therapeutics, Inc...announced that Takeda received regulatory approval for HYQVIA [Immune Globulin Infusion 10% (Human) with Halozyme's Recombinant Human Hyaluronidase] by the Japanese Ministry of Health, Labour and Welfare (MHLW) for patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)....The MHLW approval is based on data from two pivotal Phase 3, open-label, non-controlled studies evaluating the efficacy, safety, tolerability and pharmacokinetics in Japanese subjects with PID (NCT05150340, NCT05513586)."

Japan approval • Immunology

HyMMy: Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Takeda | Trial primary completion date: Jul 2025 ➔ Feb 2027

Real-world evidence • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Takeda Announces Approval of HYQVIA 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia (Businesswire) - "Takeda...today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)....The approval is based on data from two pivotal Phase 3, open-label, non-controlled studies evaluating the efficacy, safety, tolerability and pharmacokinetics in Japanese subjects with PID..."

Japan approval • CNS Disorders • Immunology • Primary Immunodeficiency • Rare Diseases

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=59 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Pain

HyMMy: Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Takeda | Trial completion date: Mar 2026 ➔ Feb 2027

Real-world • Real-world evidence • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Indirect Treatment Comparison of Efgartigimod vs Immunoglobulins in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ISPOR-EU 2024) - "Among the studies that met the predefined criteria, an ITC was considered feasible against Privigen, Hizentra, and HyQvia. Despite the limitations of the analysis and the limited comparability of the studies, the ITC results indicate that efgartigimod has a comparable or better efficacy profile than EMA-approved immunoglobulins. Further prospective comparative studies are needed to confirm these results."

Pain

HYbISCUE: A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Takeda

New trial • Real-world • Real-world evidence • Pain