Novartis ends mid-stage Fabhalta trial targeting serious kidney condition (updated)

Novartis AG

Mon 08:28

Updates Oct 16 story with company comment in bullet points 4-5
Oct 19 (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
"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 Bengaluru
Editing by Shilpi Majumdar and David Goodman
)
 ((Kamal.Choudhury@thomsonreuters.com))