Novartis Ends Mid-Stage Trial for Fabhalta in Lupus Nephritis

3-line summary

• Novartis halted a mid-stage trial testing Fabhalta in patients with lupus nephritis, according to the US federal clinical-trials registry, updated October 15. The company cited 'strategic considerations' for the decision, made after completing Part 1; the registry listing did not provide further explanation, and did not indicate whether safety or efficacy concerns influenced the decision.
• The trial was evaluating whether the oral drug, used alongside standard treatment, was safe and effective for lupus nephritis — severe kidney inflammation caused by the autoimmune disease lupus.
• Fabhalta was first approved by the FDA in 2023 for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, and has since been approved for two kidney diseases, IgA nephropathy and C3 glomerulopathy; the article did not address whether this trial halt affects those approved indications.

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