Novartis ends mid-stage trial for Fabhalta in lupus nephritis
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Investing.com -- Novartis has stopped a mid-stage clinical trial testing Fabhalta in patients with lupus nephritis, according to a federal clinical trials registry. The Swiss drugmaker cited "strategic considerations" for the decision.
The trial was testing whether the oral medication was safe and effective for treating lupus nephritis when combined with standard medical care. Lupus nephritis is a severe kidney inflammation caused by the autoimmune disease lupus.
The government database, last updated on October 15, shows Novartis decided to stop the study after completing the first part. The registry does not provide additional explanation and does not indicate whether safety or effectiveness concerns influenced the decision.
The U.S. Food and Drug Administration first approved Fabhalta in 2023 for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. The drug has since received approval for two kidney diseases: IgA nephropathy and C3 glomerulopathy.
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