Shots:
- Vera has reported the P-III (ORIGIN 3) trial data assessing Trutakna vs PBO in adults with primary IgAN at risk for disease progression, which met all of its prespecified endpoints. The company is planning to submit an sBLA to the FDA for full approval in Q4’26
- In 428 pts, Trutakna preserved kidney function at 52wks. (eGFR change: -0.1 vs -5.7 mL/min/1.73m²), slowed the 104wk. annualized eGFR decline (-0.6 vs -5.6) & reduced the risk of composite kidney disease progression by 76% (11 vs 38 events)
- Trial showed no pts requiring dialysis ≥30 days, transplant or experiencing death through 104wks. vs 8 pts on PBO; eGFR results aligned with the KDIGO treatment goal, while proteinuria, Gd-IgA1 & hematuria were also significantly reduced
Ref: Vera Therapeutics | Image: Vera Therapeutics | Press Release
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