Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

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…

ByRidhi RastogiFebruary 13, 2026

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

Shots: China’s NMPA has granted full approval to sNDA of Nefecon to reduce kidney function loss in adults with primary IgAN at risk of disease progression, regardless of their proteinuria levels Approval was based on global P-III (NefIgArd) trial assessing Nefecon (16mg, QD, PO) vs PBO in above pts on RASi therapy over 2yrs. (9mos.…

ByRidhi RastogiMay 8, 2025

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 Trial assessed atrasentan (0.75mg, PO, QD) +…

ByDipanshu DixitApril 3, 2025

Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

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