Can Novartis' Fabhalta Strengthen Its Nephrology Franchise?
Novartis NVS announced that the FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
This traditional approval converts the drug's August 2024 accelerated approval, which was based on reduction of proteinuria in primary IgAN, into a full approval after a priority review.
Fabhalta is an oral Factor B inhibitor designed to selectively target the alternative complement pathway, one of the key drivers of glomerular inflammation and kidney damage in IgAN.
The approval is supported by data from the phase III APPLAUSE-IgAN study, in which Fabhalta significantly slowed kidney function decline compared with placebo over two years. Patients treated with Fabhalta recorded an annualized decline in estimated glomerular filtration rate (eGFR) of 3.0 mL/min/1.73 m² per year versus 5.7 mL/min/1.73 m² per year for placebo, demonstrating a clinically meaningful benefit.
Fabhalta also showed a favorable safety profile consistent with previous studies.
The drug has received regulatory approvals in multiple complement-mediated diseases, including IgAN, and is being evaluated across a range of rare kidney conditions.
Fabhalta sales of $169 million more than doubled in the first quarter of 2026, reflecting continued expansion in paroxysmal nocturnal hemoglobinuria and renal indications.
The approval further strengthens Novartis' kidney disease portfolio. In addition to Fabhalta, the company’s renal disease portfolio includes Vanrafia (atrasentan) and investigational candidate zigakibart for IgAN, reinforcing its long-term growth strategy in nephrology.
Per NVS, Vanrafia is the first and only selective endothelin A receptor antagonist approved for primary IgAN. Vanrafia received accelerated approval in the United States and China for reduction of proteinuria in adults with IgAN in 2025.
Competition for NVS in Kidney Disease Market
Travere Therapeutics TVTX is focused on developing and commercializing therapies for rare kidney and metabolic diseases. TVTX’s lead drug, Filspari (sparsentan), is approved in the United States to slow kidney function decline in adults with primary IgAN at risk of disease progression and to reduce proteinuria in adult and pediatric patients (aged 8 years and older) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
Travere Therapeutics continues to see strong commercial momentum for Filspari, supporting its revenue growth.
Beyond Filspari, Travere Therapeutics is advancing pegtibatinase as a potential treatment for classical homocystinuria, a rare inherited metabolic disorder that can cause serious complications affecting the eyes, skeleton, circulatory system and central nervous system.
Vertex Pharmaceuticals VRTX recently announced that the FDA has accepted its biologics license Application (BLA) for povetacicept, an investigational dual BAFF/APRIL inhibitor for adults with immunoglobulin A nephropathy (IgAN). The FDA has assigned a target action date of Nov. 30, 2026.
If approved, VRTX will launch the first commercial product in its emerging nephrology franchise.
The approval would strengthen Vertex Pharmaceuticals' long-term growth strategy by expanding beyond cystic fibrosis into nephrology.
NVS Price, Valuation and Estimates
Year to date, shares of Novartis have gained 10.8% compared with the industry’s growth of 8.7%.
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From a valuation standpoint, NVS is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, shares currently trade at 16.447X forward earnings, higher than its mean of 13.67X but lower than the large-cap pharma industry’s 18.46X.
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The Zacks Consensus Estimate for 2026 EPS has moved south to $8.76 from $8.87 in the past 60 days, while that for 2027 has moved south to $9.72 from $9.83 in the same time frame.
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Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).
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