Novartis ends mid-stage Fabhalta trial targeting serious kidney condition

Oct 19 — 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

• "The decision ‌was based on strategic ​considerations and was not driven by any interim efficacy or safety findings," the company said, adding that other studies with the drug will continue as planned

• Investigators for the terminated trial have been notified and are ​engaging with participants regarding next steps, Novartis ‌added

• Endpoints News ‌reported ⁠the development on Friday

• 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 BengaluruEditing by Shilpi Majumdar and David ​Goodman)

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