Novartis ends mid-stage trial for Fabhalta in lupus nephritis

Novartis has discontinued a mid-stage clinical trial examining the oral medication Fabhalta's safety and efficacy in treating lupus nephritis, a severe kidney inflammation caused by the autoimmune disease lupus. The Swiss pharmaceutical company cited strategic considerations as the reason for the decision to halt the study, which was documented in the federal clinical trials registry on October 15.

The trial aimed to evaluate whether Fabhalta, when used alongside standard medical care, could be safe and effective for patients with lupus nephritis. However, the registry does not provide further information on whether safety or effectiveness concerns played a role in the decision. Fabhalta, which received FDA approval in 2023 for treating paroxysmal nocturnal hemoglobinuria, a rare blood disorder, has since been approved for two kidney diseases: IgA nephropathy and C3 glomerulopathy.