Takeda's TAK-881 shows PK comparability to HYQVIA and halves infusion volume

Trial and design

The pivotal Phase 2/3 IgGNITE trial (TAK‑881‑3001) evaluated TAK‑881 (SCIG 20% with recombinant human hyaluronidase) in patients with primary immunodeficiency aged ≥2 years. Participants ≥16 years entered a randomized crossover comparing TAK‑881 and HYQVIA; those <16 years were enrolled in a single‑arm cohort. Results for participants ≥16 were presented at ESID 2026.

Pharmacokinetics and dosing

TAK‑881 met the primary endpoint, demonstrating equivalent IgG exposure to HYQVIA. Steady‑state trough geometric means were 11.7 g/L for TAK‑881 and 11.9 g/L for HYQVIA, remaining above accepted protective thresholds while supporting up to once‑monthly dosing.

Administration and infusion metrics

The 20% formulation delivered the same bodyweight‑adjusted IG dose in 50% less volume. Median infusion durations were reduced (one site: 75.8 vs 132 minutes; two sites: 58.3 vs 86 minutes) at a median maximum tolerated rate of 300 mL/hour/site, potentially enabling fewer infusion sites.

Efficacy, safety and next steps

Descriptive analyses showed low annualized infection rates and a low annualized serious bacterial infection rate, with maintained protective IgG troughs. TEAEs occurred in 56.1% on TAK‑881 versus 50.0% on HYQVIA; no TAK‑881‑related Grade ≥3 TEAEs or TAK‑881‑related serious adverse events were identified. Nine of 43 randomized participants (20.9%) discontinued across both periods. Long‑term safety is being evaluated in the ongoing TAK‑881‑3002 extension. Takeda expects to submit regulatory applications in the US, EU and Japan in fiscal 2026.