Roche’s Phase 3 kidney-drug win sets up a fight with Novartis

Roche and Ionis reported a Phase 3 success for sefaxersen, an investigational monthly injectable targeting complement factor B in primary IgA nephropathy (IgAN), an autoimmune kidney disease.

The IMAgINATION trial met its interim primary endpoint at week 37, showing a statistically significant and clinically meaningful reduction in proteinuria versus placebo. Proteinuria is an important marker of kidney damage.

The 459-patient trial will continue through week 105 to measure eGFR, the more direct indicator of preserved kidney function. Roche plans to discuss the interim results with regulators, potentially seeking an accelerated approval pathway.

If approved, sefaxersen would enter a crowded and potentially lucrative IgAN market, where therapies can cost roughly $400,000–$500,000 annually and aim to delay dialysis or transplantation.

The clearest competitive matchup is with Novartis’ Fabhalta (iptacopan), an oral, twice-daily Factor B inhibitor. Roche’s monthly subcutaneous dosing—and possible home use with an autoinjector—could offer a convenience advantage.

Sefaxersen still faces competition from approved or late-stage medicines from Otsuka, Vera Therapeutics, Travere, Vertex, and others. Its longer-term kidney-function results and regulatory review will be crucial to determining whether it can become a blockbuster.