Takeda says IgGNITE Phase 2/3 trial shows TAK-881 matches HyQvia pharmacokinetics in PID patients 16+
TAK•Takeda said its Phase 2/3 IgGNITE trial met its primary endpoint, showing investigational TAK-881 had pharmacokinetics comparable to HYQVIA in patients aged 16 and older. Takeda plans regulatory submissions in the US, EU and Japan in fiscal 2026.
1. Trial results
Takeda presented detailed IgGNITE results for investigational subcutaneous TAK-881 at ESID 2026. The study met its primary endpoint, supporting comparability with HYQVIA; descriptive findings indicated similar infection protection, safety and tolerability, with no new safety signals.
2. Potential administration changes
Takeda said lower-volume dosing could enable shorter infusions and fewer infusion sites than HYQVIA. Regulatory submissions in the US, EU and Japan are planned in fiscal 2026.
