Shots:
- The global P-III (ALIGN) trial assessed Vanrafia (0.75mg, QD, PO) vs PBO for 132wks. in 340 IgAN pts at risk of progressive loss of kidney function. An additional 64 pts received an SGLT2 inhibitor alongside a RAS inhibitor for at least 12wks.
- In the trial, Vanrafia showed a 2.39 mL/min/1.73m² difference in eGFR change from baseline at Wk. 136. At Wk. 132, the treatment difference was 2.59 mL/min/1.73m², with clinically meaningful benefits also seen in pts receiving SGLT2 inhibitors
- Additionally, Vanrafia received accelerated approval in the US & China in 2025 to reduce proteinuria in adults with IgAN, with Novartis planning to seek traditional approval in 2026
Ref: Globenewswire | Image: Novartis | Press Release
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