AstraZeneca AZN announced that the FDA has accepted a regulatory filing seeking to expand the use of its blockbuster rare disease drug, Ultomiris (ravulizumab), for immunoglobulin A nephropathy (IgAN), a rare progressive kidney disease.
The FDA has granted the filing priority review, shortening the review period by four months. A final decision is expected in the fourth quarter of 2026.
If approved, Ultomiris will be the first C5 complement inhibitor available for IgAN. The drug is currently approved in the United States, Europe and Japan across four indications. These include atypical haemolytic uraemic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and paroxysmal nocturnal haemoglobinuria (PNH).
The FDA filing is supported by interim data from the late-stage I CAN study, which showed that treatment with the drug for 34 weeks led to a statistically significant and clinically meaningful reduction in proteinuria (protein in urine). Per AstraZeneca, Ultomiris demonstrated a 43.4% reduction in proteinuria compared to placebo.
A potential approval would broaden the commercial potential of the drug, which is currently one of AstraZeneca’s key growth drivers. In first-quarter 2026, Ultomiris generated $1.27 billion in sales, up 18% year over year, driven by strong demand across approved indications, geographic expansion and continued patient conversion from Soliris.
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Other Players in the IgAN Space
If approved, Ultomiris will likely compete with Calliditas Therapeutics’ Tarpeyo, Novartis’ NVS Fabhalta and Travere Therapeutics’ TVTX 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 (C3G) and PNH indications.
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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.
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