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FDA Grants Accelerated Approval to NVS Kidney Disease Drug
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Novartis (NVS - Free Report) obtains FDA approval of atrasentan, a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval was granted on an accelerated basis.
The candidate got approval under the brand name Vanrafia.
IgAN is a progressive, rare kidney disease. Approximately 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis.
The approval Vanrafia marks the third drug approval for Novartis in its renal disease portfolio.
Vanrafia is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor.
The accelerated approval from the FDA was based on a prespecified interim analysis of the late-stage ALIGN study, which measured the reduction of proteinuria at 36 weeks compared to placebo.
In this ongoing phase III ALIGN study, patients receiving Vanrafia in combination with a RAS inhibitor achieved a clinically meaningful and statistically significant proteinuria reduction of 36.1% compared to placebo, with results observed as early as week 6 and sustained through week 36.
The ALIGN study showed that Vanrafia has a favorable safety profile consistent with previously reported data.
However, the available data doesn’t substantiate whether Vanrafia slows kidney function decline in patients with IgAN.
The continued approval of Vanrafia may be contingent upon verification of clinical benefit from the ongoing phase III ALIGN study, which evaluates whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136.
Novartis expects eGFR data in 2026. This data is intended to support traditional FDA approval.
The approval of Vanrafia strengthens Novartis’ renal portfolio, which comprises Fabhalta.
This is the third approval received by Novartis in the United States for its kidney disease portfolio in the past year.
Last month, the regulatory body approved Fabhalta for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria. The drug was granted accelerated approval for the indication of IgAN in August 2024.
Fabhalta obtained FDA and European Commission approval in December 2023 and May 2024, respectively, for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
Novartis is evaluating Fabhalta in a broad range of rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis and lupus nephritis.
Novartis is also evaluating zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody that is currently in phase III development in IgAN, with results expected in 2026.
Approval of new drugs and label expansion of existing drugs should further fuel sales in the wake of generic competition for Tasigna, Promacta and Entresto. Novartis has a deep pipeline with a number of promising candidates (remibrutinib, ianalumab, pelacarsen and zigakibart).
In the past 30 days, Bayer’s earnings per share (EPS) estimate for 2025 has increased to $1.19 from $1.14. During the same timeframe, the figure for 2026 has increased to $1.28 from $1.23. Shares of BAYRY have surged 15% in the past three months.
Gilead Sciences
In the past 60 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.55 to $7.87. During the same timeframe, the figure for 2026 has increased to $8.31 from $8.17. Shares of GILD have surged 20% year to date.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
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FDA Grants Accelerated Approval to NVS Kidney Disease Drug
Novartis (NVS - Free Report) obtains FDA approval of atrasentan, a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval was granted on an accelerated basis.
The candidate got approval under the brand name Vanrafia.
IgAN is a progressive, rare kidney disease. Approximately 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis.
The approval Vanrafia marks the third drug approval for Novartis in its renal disease portfolio.
Shares of Novartis have risen 16.5% year to date compared with the large cap pharmaceutical industry’s growth of 1.6%.
Image Source: Zacks Investment Research
More on NVS’ Vanrafia
Vanrafia is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor.
The accelerated approval from the FDA was based on a prespecified interim analysis of the late-stage ALIGN study, which measured the reduction of proteinuria at 36 weeks compared to placebo.
In this ongoing phase III ALIGN study, patients receiving Vanrafia in combination with a RAS inhibitor achieved a clinically meaningful and statistically significant proteinuria reduction of 36.1% compared to placebo, with results observed as early as week 6 and sustained through week 36.
The ALIGN study showed that Vanrafia has a favorable safety profile consistent with previously reported data.
However, the available data doesn’t substantiate whether Vanrafia slows kidney function decline in patients with IgAN.
The continued approval of Vanrafia may be contingent upon verification of clinical benefit from the ongoing phase III ALIGN study, which evaluates whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136.
Novartis expects eGFR data in 2026. This data is intended to support traditional FDA approval.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
NVS’ Renal Portfolio Gets a Boost
The approval of Vanrafia strengthens Novartis’ renal portfolio, which comprises Fabhalta.
This is the third approval received by Novartis in the United States for its kidney disease portfolio in the past year.
Last month, the regulatory body approved Fabhalta for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria. The drug was granted accelerated approval for the indication of IgAN in August 2024.
Fabhalta obtained FDA and European Commission approval in December 2023 and May 2024, respectively, for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
Novartis is evaluating Fabhalta in a broad range of rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis and lupus nephritis.
Novartis is also evaluating zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody that is currently in phase III development in IgAN, with results expected in 2026.
Approval of new drugs and label expansion of existing drugs should further fuel sales in the wake of generic competition for Tasigna, Promacta and Entresto. Novartis has a deep pipeline with a number of promising candidates (remibrutinib, ianalumab, pelacarsen and zigakibart).
NVS Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Bayer (BAYRY - Free Report) and Gilead Sciences (GILD - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bayer
In the past 30 days, Bayer’s earnings per share (EPS) estimate for 2025 has increased to $1.19 from $1.14. During the same timeframe, the figure for 2026 has increased to $1.28 from $1.23. Shares of BAYRY have surged 15% in the past three months.
Gilead Sciences
In the past 60 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.55 to $7.87. During the same timeframe, the figure for 2026 has increased to $8.31 from $8.17. Shares of GILD have surged 20% year to date.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.