Novartis released final Phase 3 results for Vanrafia (atrasentan), its conditionally approved treatment for IgA nephropathy, reinforcing the drug's ability to slow the progression of kidney function decline in adult patients. The ALIGN study showed a 2.39 ml/min/1.73m² difference in estimated glomerular filtration rate (eGFR) change compared to placebo at Week 136, with enhanced efficacy demonstrated at Week 132, supporting the drug's therapeutic profile over an extended treatment period.
The data strengthen Novartis's regulatory pathway forward, as the company prepares to transition Vanrafia from its conditional approval status—granted in April 2025—to traditional full approval. The company has announced plans to submit for traditional approval in 2026, contingent on the positive long-term outcomes demonstrated in the ALIGN trial.
IgA nephropathy, the most common form of glomerulonephritis globally, progresses to kidney failure in approximately 40% of patients within two decades. Vanrafia's demonstrated capacity to slow eGFR decline addresses a significant clinical need in this patient population, where treatment options remain limited. The transition to full approval would expand access to the medication and provide additional confirmation of its clinical benefit and safety profile.