Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 5
- 1 min read
05/06/2026
Otsuka presented interim Phase 3 data showing sibeprenlimab preserved kidney function over 12 months in IgAN (Ref)
Otsuka Pharmaceutical announced that VOYXACT® (sibeprenlimab-szsi; APRIL inhibitor) preserved kidney function compared to placebo over 12 months in adults with primary IgA nephropathy (IgAN) at risk for disease progression.
At 12 months, VOYXACT preserved kidney function by showing a mean eGFR change from baseline of +0.7 compared to a decline of -4.8 mL/min/1.73 m² in the placebo-treated arm, representing a treatment effect of 5.5 mL/min/1.73 m².
Otsuka initiated a rolling submission of a supplemental Biologics License Application (sBLA) to the US FDA for VOYXACT traditional approval, based on the 24-month eGFR endpoint data.
InnoCare presented Phase 2b results for Orelabrutinib in patients with SLE at EULAR-2026 (Ref)
InnoCare Pharma announced study results for orelabrutinib (BTK inhibitor) in patients with systemic lupus erythematosus (SLE), results were presented at the EULAR-2026.
The study of orelabrutinib for SLE met its primary and secondary endpoints.
The study showed that orelabrutinib significantly reduced disease activity and glucocorticoid dosage, and exhibited a favorable trend toward SLE relapse delay and biomarkers improvement.
Orelabrutinib was safe and well tolerated in participants with SLE.
The company was accelerating the patient enrollment for the registrational Phase 3 trial of orelabrutinib for the treatment of SLE.
