Novartis ends mid-stage Fabhalta trial targeting serious kidney condition

By Reuters News

Oct 16 (Reuters) - Swiss drugmaker Novartis NOVN.S 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

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