Roche reports phase 3 success for sefaxersen in IgA nephropathy, eyes accelerated approval

Roche announced that its experimental drug sefaxersen met the primary endpoint in a phase 3 trial for IgA nephropathy, showing reduced proteinuria versus placebo.

The interim analysis at week 37 demonstrated a statistically significant drop in 24‑hour protein‑to‑creatinine ratio, with safety consistent with earlier studies. The study will stay blinded for kidney function outcomes through week 105.

Roche plans to discuss the data with regulators, hoping the proteinuria reduction could support an accelerated approval pathway. Analysts estimate potential sales around €400 million, positioning the drug against Novartis in the kidney disease market.