Annuncio • May 06

Takeda Pharmaceutical Company Limited Announces Positive Topline Results From Pivotal Phase 2/3 Clinical Trial Of TAK-881 In Primary Immunodeficiency Disease

Takeda Pharmaceutical Company Limited announced that TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) with Recombinant Human Hyaluronidase] and HYQVIA [Immune Globulin Infusion (Human) 10% with Recombinant Human Hyaluronidase]. Additionally, secondary endpoints showed that TAK-881, a SCIG 20% facilitated with hyaluronidase, demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA, an established SCIG 10% facilitated with hyaluronidase. These findings support the potential of TAK-881 to deliver the required immunoglobulin (IG) dose for PID patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PID). The TAK-881-3001 clinical trial evaluated the PK, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with PID previously treated with IG therapy and compared them with HYQVIA in patients aged 16 years and older. Initial topline data show TAK-881: Achieved comparable PK: The study met its primary endpoint demonstrating equivalent immunoglobulin G (IgG) exposure between TAK-881 and HYQVIA as shown by a geometric mean ratio of 99.67% (90% CI: 95.10% to 104.46%) for the areas under the concentration-time profiles over one dosing interval at the steady state (AUC0-tau, ss). Provided immune protection: TAK-881 demonstrated comparable infection rates and immune protection to HYQVIA, with protective IgG levels consistently maintained throughout the study. Demonstrated a comparable safety profile: The safety and tolerability profiles of TAK-881 shown were comparable to HYQVIA, with no new safety signals observed. The safety profile of TAK-881 will continue to be evaluated in the ongoing TAK-881-3002 extension study. Analyses from TAK-881-3001 are ongoing, and Takeda anticipates sharing additional results in an upcoming medical forum. Takeda expects to submit applications for TAK-881 to regulatory authorities in the United States, European Union and Japan in fiscal year 2026. TAK-881-3001 was a pivotal Phase 2/3 clinical trial evaluating the pharmacokinetics, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with Primary Immunodeficiency Disease (PID) who were previously treated with immunoglobulin (IG) therapy. Study participants aged 16 and older were randomized to be treated with TAK-881 followed by HYQVIA or HYQVIA followed by TAK-881 with the same dose and dosing interval of IG for up to 51 weeks in the open label, randomized cross-over study part. Participants aged 2 to < 16 were treated with only TAK-881 for up to 27 weeks in the open label single-arm study part. TAK-881-3002 is a Phase 3 study evaluating the long-term safety and tolerability of TAK-881 in patients with PID and is the extension study of TAK-881-3001. TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) and Recombinant Human Hyaluronidase] is an investigational liquid medicine comprised of one vial of immunoglobulin (IG) 20% and one vial of Halozyme’s recombinant human hyaluronidase (rHuPH20). IG is collected from human plasma and maintains the body’s immune system. TAK-881 is infused under the skin into the fatty subcutaneous tissue where the hyaluronidase facilitates the dispersion and increases the absorption of immunoglobulin in the subcutaneous tissue, allowing larger volumes to be infused at a given infusion site. As a SCIG 20% facilitated with hyaluronidase, TAK-881 is being developed with the goal of reducing infusion volume and duration while providing effective immune protection for patients with PID. Primary Immunodeficiency Disease (PID) is a group of more than 550 rare and chronic disorders, where a part of the body’s immune system is missing or does not function the way it should. These conditions result from genetic mutations, which are usually inherited. The symptoms of PID vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists. In the United States, PID affects about 1 in 1,200 people. HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing immunoglobulin (IG) 10% and Halozyme’s recombinant human hyaluronidase (rHuPH20). HYQVIA is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents (0-18 years) with Primary Immunodeficiency Disease (PID) with impaired antibody protection and with Secondary Immunodeficiency Disease (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of to treat adults and children two years of age and older with PID as a well as a maintenance therapy for adult patients with CIDP. HYQVIA is infused under the skin into the fatty subcutaneous tissue and contains IG collected from human plasma. IGs are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PID). HyQvia (Human normal immunoglobulin) 100 mg/ml solution for infusion for subcutaneous use. Important Safety Information (European Union): Please consult the HyQvia (Human normal immunoglobulin (SCIg)) Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring. GUIDANCE FOR USE: Therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency/CIDP. The medicinal product should be administered via the subcutaneous (SC) route. The dose and dose regimens are dependent on the indication. The dose may need to be individualized for each patient dependent on the PK and clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients.

Indice di copertura degli interessi	4.6x
Contanti	JP¥595.05b
Patrimonio netto	JP¥7.43t
Totale passività	JP¥8.08t
Totale attività	JP¥15.51t

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/06/29 21:47
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Atsushi Seki	Barclays
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