Novartis Announces Phase III Results for Vanrafia, Slowing Kidney Function Decline
Novartis announced final results from the Phase III ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy who were treated with Vanrafia. Vanrafia showed a difference of 2.39 ml/min/1.73m2 in estimated glomerular filtration rate change from baseline vs. placebo at Week 136, 4 weeks after the end of study treatment. Clinically meaningful results were observed with Vanrafia compared to placebo in eGFR change from baseline at the end of study treatment at Week 132, and in the prespecified exploratory group of patients additionally receiving sodium-glucose co-transporter-2 inhibitors. At the end of treatment at Week 132, the eGFR change from baseline compared to placebo was 2.59 ml/min/1.73 m2. Vanrafia received accelerated approval in U.S. and China for reduction of proteinuria in adults with IgAN in 2025; Novartis plans to submit for traditional approval in 2026.
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- Deal Scale: Unnatural Products has entered into a research and licensing agreement with Novartis worth up to $1.8 billion, aimed at developing orally delivered peptide therapies for cardiovascular diseases, showcasing a powerful collaboration in the biopharmaceutical sector.
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- Study Overview: Novartis's ALIGN study indicates that Vanrafia (atrasentan) slows the decline of kidney function in IgA nephropathy patients, with a clinically meaningful eGFR change of 2.39 ml/min/1.73m² compared to placebo, highlighting its potential in chronic kidney disease management.
- Accelerated Approval Context: Vanrafia received accelerated approval in April 2025 in the U.S. and China for reducing proteinuria in IgAN patients, with Novartis planning to submit for traditional approval in 2026 to further validate its clinical benefits.
- Long-Term Follow-Up Advantage: The ALIGN study provides the longest follow-up period in pivotal Phase 3 studies for IgAN, ensuring a thorough assessment of Vanrafia's long-term effects, with safety consistent with previous findings, bolstering confidence in its market prospects.
- Market Reaction: Novartis shares rose 0.42% to $161.86 in premarket trading on Friday, nearing its 52-week high of $162.31, reflecting positive market expectations regarding the potential success of the drug.









