Otsuka Holdings Co.,Ltd. [4578.T]
TOKYO, Jun 05 (Pulse News Wire) – Otsuka Holdings CO.,LTD. (4578.T) announced positive kidney function data for its IgA nephropathy treatment drug VOYXACT® (sibeprenlimab) in a phase 3 trial presented at the European Renal Association conference in Glasgow.
After 12 months, patients treated with sibeprenlimab showed an average eGFR increase of +0.7 mL/min/1.73 m² compared to a decrease of -4.8 mL/min/1.73 m² in the placebo group, indicating sustained kidney function. Dr.
Vlado Perkovic, executive director of The George Institute Australia, highlighted the significance of maintaining kidney function in IgA nephropathy patients, noting that the data suggests potential for long-term improvement through selective APRIL inhibition. John Kraus, senior vice president and chief medical officer at OPDC, emphasized the clinical evidence supporting sibeprenlimab's ability to improve outcomes without depleting B cells, which produce antibodies involved in disease pathology.
Based on these results, Otsuka has initiated a staged submission process for a biologics license application amendment (sBLA) to the FDA, aiming for full approval based on final phase 3 trial results, including 24-month eGFR evaluation data.
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