STAT+: Vera kidney drug Trutakna shows strong final results in Phase 3 trial — SkimNews
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- Vera Therapeutics released final two-year data from a Phase 3 trial showing Trutakna stabilized kidney function and reduced the risk of kidney-related death or complications in IgA nephropathy patients
- Trutakna received accelerated FDA approval in July for treating IgA nephropathy, a chronic autoimmune kidney disease marked by immune antibody buildup in the kidneys
- Vera Therapeutics plans to submit an application for full FDA approval of Trutakna in the fourth quarter, based on the completed Phase 3 trial results
- IgA nephropathy can lead to progressive kidney function loss and may result in organ failure requiring dialysis, according to the company's description of the disease
Why it matters: Patients with IgA nephropathy gain a potential disease-modifying therapy backed by two-year trial data, while Vera Therapeutics moves closer to converting accelerated approval into full FDA clearance—locking in commercial viability and reducing regulatory uncertainty for the drug’s future.
Ask SkimNews
