Novartis (NVS) 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, a severe inflammation of the kidneys caused by the autoimmune disease lupus, when added to standard medical care.
The government database, last updated on October 15, shows the Swiss drugmaker decided to conclude the study after completing its first part.
“The decision was based on strategic considerations and was not driven by any interim efficacy or safety findings,” Novartis 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, the company said.
The US Food and Drug Administration 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.