武田在ESID 2026公布TAK-881治疗PID的III期详细数据：输注时间缩短42.6%，但阳性topline早在5月已披露

Takeda Pharmaceutical Company Limited (TAK), a biopharmaceutical company developing treatments for rare diseases and other conditions, presented detailed Phase 2/3 IgGNITE study results for its investigational subcutaneous therapy TAK-881 in patients with Primary Immunodeficiency Disease (PID) at the 2026 meeting of the European Society for Immunodeficiencies (ESID).
The study met its primary endpoint, demonstrating pharmacokinetic comparability between TAK-881 and HYQVIA, an approved immunoglobulin replacement therapy.
In patients aged 16 years and older, TAK-881 demonstrated comparable immunoglobulin G (IgG) exposure, infection outcomes, and safety and tolerability profiles based on descriptive analyses.
TAK-881 delivered the same immunoglobulin dose in 50% less volume than HYQVIA. Median infusion time was reduced by 56.2 minutes, or 42.6%, when administered through one infusion site, and by 27.7 minutes when using two infusion sites.
The investigational therapy maintained dosing potential of up to once every three to four weeks.
Primary Immunodeficiency Disease comprises a group of rare, often inherited disorders in which part of the immune system is missing or does not function properly.
Patients frequently require lifelong immunoglobulin replacement therapy to help protect against infections. However, infusion volume and administration time can contribute to the burden of ongoing treatment.
In the study, mean annualized infection rates were 2.62 with TAK-881 and 2.73 with HYQVIA. Mean IgG trough concentrations were 11.7 g/L and 11.9 g/L, respectively, remaining above accepted protective thresholds against infections.
TAK-881 was generally well tolerated, with no new safety signals or TAK-881-related serious adverse events identified compared with HYQVIA.
Treatment-emergent adverse events occurred in 56.1% of participants receiving TAK-881 and 50.0% receiving HYQVIA. No TAK-881-related adverse events led to study discontinuation.
The pivotal Phase 2/3 IgGNITE study evaluated the pharmacokinetics, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and children aged two years and older with PID who had previously received immunoglobulin therapy.
Participants aged 16 years and older underwent a randomized crossover comparison of TAK-881 and HYQVIA, while younger participants received TAK-881 in a separate study cohort.
TAK-881 is an investigational 20% subcutaneous immunoglobulin formulation combined with recombinant human hyaluronidase. The therapy is designed to facilitate immunoglobulin absorption under the skin while potentially reducing infusion volume and administration time.
Takeda expects to submit regulatory applications for TAK-881 in the United States, European Union and Japan during fiscal year 2026. If approved, the therapy could offer patients with PID an additional immunoglobulin replacement option with reduced infusion volume and shorter administration times.
TAK has traded in a 52-week range of $12.99 to $19.10. Currently, TAK is trading at $18.66, up 0.76%.
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