Oct 16 (Reuters) – Swiss drugmaker Novartis has terminated a mid-stage study testing its drug Fabhalta in patients with a serious kidney condition, citing “strategic considerations”, according to a federal clinical trials registry.
• The trial was evaluating whether the oral medication was safe and effective for treating lupus nephritis when added to standard medical care
• Lupus nephritis is a severe inflammation of the kidneys caused by the autoimmune disease lupus
• The government database, last updated on October 15, shows Novartis decided to conclude the study after completing the first part
• It gives no other explanation and does not say whether safety or effectiveness played a role
• Endpoints News reported the development earlier on Friday
• Novartis did not immediately respond to a Reuters request for comment
• The US FDA first approved Fabhalta in 2023 for a rare blood disorder called PNH. It has since been approved for two kidney diseases, IgA nephropathy and C3 glomerulopathy
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)
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