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AstraZeneca Gets Accelerated FDA Nod for Ultomiris in IgA Nephropathy
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Key Takeaways
AZN's Ultomiris gains accelerated FDA approval to reduce proteinuria in adults with progressive-risk IgAN.
Ultomiris' latest FDA nod marks its fifth U.S. indication, expanding its reach across various rare diseases.
Ultomiris sales rose 14% to $2.58 billion in the first half of 2026, driven by demand & geographic expansion.
AstraZeneca (AZN - Free Report) announced that the FDA has approved its blockbuster rare disease drug, Ultomiris (ravulizumab), for reducing proteinuria (protein in urine) in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
Following the latest nod, Ultomiris became the first and only C5 complement inhibitor to be approved in the United States for this indication.
The indication is approved under the FDA's accelerated approval pathway and is based on the reduction in proteinuria. It has not yet been established whether Ultomiris slows kidney function decline in patients with IgAN. The ongoing phase III I CAN study is evaluating changes in estimated glomerular filtration rate (eGFR) at week 106, with results intended to support traditional FDA approval.
Year to date, shares of AstraZeneca have declined 7.4% against the industry’s increase of 6.7%.
Image Source: Zacks Investment Research
FDA Nod Based on AZN’s Late-Stage I CAN Study
The FDA approval was based on interim data from the phase III I CAN study, which showed that treatment with Ultomiris for 34 weeks led to a statistically significant and clinically meaningful reduction in proteinuria. Per AstraZeneca, Ultomiris demonstrated a 43.4% reduction in proteinuria compared to placebo.
The safety profile of Ultomiris in the study was consistent with its established profile, with no new safety concerns identified.
Ultomiris is administered intravenously every eight weeks following a loading dose, with dosing based on body weight. The latest approval marks its fifth indication in the United States, expanding its use across complement-mediated diseases.
The drug is currently approved in the United States, Europe and Japan across four indications. These include atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and paroxysmal nocturnal hemoglobinuria (PNH).
In the first six months of 2026, Ultomiris generated $2.58 billion in sales, up 14% year over year, driven by strong demand across approved indications, geographic expansion and continued patient conversion from Soliris.
AZN’s Competition in the IgAN Space
Ultomiris is likely to compete with Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — slowing the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
Novartis’ Fabhalta is approved under the accelerated pathway for reducing proteinuria in adults with primary IgAN who are at risk of rapid disease progression. The NVS drug is also approved for complement 3 glomerulopathy and PNH indications.
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AstraZeneca Gets Accelerated FDA Nod for Ultomiris in IgA Nephropathy
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the FDA has approved its blockbuster rare disease drug, Ultomiris (ravulizumab), for reducing proteinuria (protein in urine) in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
Following the latest nod, Ultomiris became the first and only C5 complement inhibitor to be approved in the United States for this indication.
The indication is approved under the FDA's accelerated approval pathway and is based on the reduction in proteinuria. It has not yet been established whether Ultomiris slows kidney function decline in patients with IgAN. The ongoing phase III I CAN study is evaluating changes in estimated glomerular filtration rate (eGFR) at week 106, with results intended to support traditional FDA approval.
Year to date, shares of AstraZeneca have declined 7.4% against the industry’s increase of 6.7%.
Image Source: Zacks Investment Research
FDA Nod Based on AZN’s Late-Stage I CAN Study
The FDA approval was based on interim data from the phase III I CAN study, which showed that treatment with Ultomiris for 34 weeks led to a statistically significant and clinically meaningful reduction in proteinuria. Per AstraZeneca, Ultomiris demonstrated a 43.4% reduction in proteinuria compared to placebo.
The safety profile of Ultomiris in the study was consistent with its established profile, with no new safety concerns identified.
Ultomiris is administered intravenously every eight weeks following a loading dose, with dosing based on body weight. The latest approval marks its fifth indication in the United States, expanding its use across complement-mediated diseases.
The drug is currently approved in the United States, Europe and Japan across four indications. These include atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and paroxysmal nocturnal hemoglobinuria (PNH).
In the first six months of 2026, Ultomiris generated $2.58 billion in sales, up 14% year over year, driven by strong demand across approved indications, geographic expansion and continued patient conversion from Soliris.
AZN’s Competition in the IgAN Space
Ultomiris is likely to compete with Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — slowing the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
Novartis’ Fabhalta is approved under the accelerated pathway for reducing proteinuria in adults with primary IgAN who are at risk of rapid disease progression. The NVS drug is also approved for complement 3 glomerulopathy and PNH indications.
AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.