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

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

Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting (Takeda Press Release) - P3 | N=138 | ADVANCE-CIDP (NCT02549170) | Sponsor: Baxalta now part of Shire | "Takeda...announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP)....The median monthly dose of HYQVIA across all patients was 64 (28.0 to 200.0) g/4 weeks. The mean infusion duration per dose of HYQVIA was 135.5 minutes with 88.2% of doses administered every 4 weeks and 92.3% of doses administered across two infusion sites. HYQVIA was well tolerated among the 3487 infusions administered; 3 (0.1%) infusions had a reduced infusion rate, were interrupted or stopped due to intolerability."

P3 data • CNS Disorders • Immunology

Precision immunomodulation: Adalimumab and Immunoglobulin replacement therapy in treating autoimmune complications of Inborn Errors of Immunity (EAACI 2024) - "Previous attempts to address the condition with steroid and methotrexate proved ineffective...Following the diagnosis of Common Variable Immunodeficiency (CVID) according to the ESID criteria, the implementation of replacement therapy with facilitated subcutaneous Immunoglobulin (fSCIg, Hyqvia 20 g/month) significantly reduced the frequency of infectious recurrences...Subsequently, treatment with subcutaneous adalimumab (40 mg sc/2 weeks) was initiated, resulting in effective control of low back pain without exacerbating infections. Conclusions We observed that incorporating Adalimumab into the treatment regimen with facilitated subcutaneous Immunoglobulin (fSCIg) was both medically safe and beneficial for patients with psoriatic spondylarthritis and Crohn's-like colitis associated with Inborn Errors of Immunity and hypogammaglobulinemia phenotype."

Immunomodulating • Crohn's disease • Immunology • Inflammatory Bowel Disease • Primary Immunodeficiency • Psoriasis • Seronegative Spondyloarthropathies • CTLA4

Assessing hyaluronidase-facilitated subcutaneous immunoglobulin 20% (fSCIG 20%) pharmacokinetics, safety and tolerability in primary immunodeficiency diseases: phase 2/3 study design (CIS 2024) - P2/3 | "Following a phase 1 tolerability/safety study inhealthy adults receiving fSCIG 20%, this phase 2/3, multicenter, open-label,randomized, two-arm crossover PK comparability registrational study(NCT05755035) will assess pharmacokinetic (PK) comparability betweenfSCIG 20% and fSCIG 10% (HYQVIA) in patients with PIDDs, as well asinfection rates, safety, tolerability, immunogenicity and infusionparameters.Part 1 will include patients aged ≥16 years with documented PIDDdiagnoses requiring IgG replacement (Figure 1; patients aged 2–< 16 yearswill participate in single-arm Part 2)...Key secondary endpoints include steady state PKparameters, including maximum concentration, time to maximum concentration and half-life, annualized rate of all infections, acute seriousbacterial infections and episodes of fever, and healthcare resourceutilization. Treatment-emergent adverse events, infusion tolerability,binding and neutralizing anti-rHuPH20 antibody development andinfusion..."

Clinical • P2/3 data • PK/PD data • Immunology • Infectious Disease • Primary Immunodeficiency

Maternal and neonate outcomes following exposure to hyaluronidasefacilitated subcutaneous immunoglobulin 10% during pregnancy: aretrospective case series based on US claims data (CIS 2024) - "The efficacy and safety of hyaluronidase-facilitated subcutaneous immunoglobulin 10% (fSCIG 10%; HYQVIA) in primary immunodeficiency diseasesare well documented in the general population...This clinical case series, extracted from a large claimsdatabase, does not raise concerns regarding the safety of fSCIG 10% useduring pregnancy. However, more evidence is needed to narrow theuncertainty around these initial observations.Study funder: Takeda Development Center Americas, Inc."

Retrospective data • Critical care • Immunology • Infectious Disease • Primary Immunodeficiency

Infusion-related Costs for HyQvia Compared to Hizentra in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (AAN 2024) - "Treatment with fSCIG-10% resulted in total annual savings of $1676 per person with CIDP. Savings are attributed to less-frequent administration, resulting in fewer per-person infusion costs and nursing hours."

Immunology • 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 | Recruiting ➔ Active, not recruiting | N=10 ➔ 15

Enrollment change • Enrollment closed • Immunology • Primary Immunodeficiency

Halozyme Announces Takeda Received European Commission Approval for HYQVIA Co-formulated with ENHANZE as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PRNewswire) - "Halozyme Therapeutics...announced that Takeda received European Commission (EC) approval for HYQVIA [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG)....The centralized marketing authorization for HYQVIA in CIDP is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland."

European regulatory • CNS Disorders • Immunology • Primary Immunodeficiency

Halozyme Announces Takeda Receives FDA Approval for HYQVIA Co-formulated with ENHANZE as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PRNewswire) - "Halozyme Therapeutics, Inc...announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. HYQVIA was first granted FDA approval in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old."

BLA • CNS Disorders • Immunology

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=71 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Immunology • Primary Immunodeficiency

Takeda Receives Positive CHMP Opinion for HYQVIA as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (Businesswire) - "Takeda...announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union....This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP."

European regulatory • CNS Disorders • Immunology

Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

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=71 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Apr 2025 ➔ Sep 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

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

A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) (clinicaltrials.gov) - P3 | N=16 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • 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 | Recruiting ➔ Active, not recruiting | Trial primary completion date: Oct 2023 ➔ Mar 2024

Enrollment closed • Trial primary completion date • Complement-mediated Rare Disorders • Pain

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP (clinicaltrials.gov) - P3 | N=85 | Completed | Sponsor: Baxalta now part of Shire | Active, not recruiting ➔ Completed

Trial completion • Pain