Novartis halts Phase 2 lupus nephritis trial of Fabhalta, cites strategic reasons
Novartis has stopped a Phase 2 study of its complement blocker Fabhalta (iptacopan) in patients with lupus nephritis, a kidney involving form of the disease.
The company said the decision was based on strategic considerations and was not driven by any interim efficacy or safety findings. The trial enrolled 81 patients and completed the first portion, which compared Fabhalta plus standard of care to placebo plus standard of care.
Novartis will continue to evaluate Fabhalta in other rare diseases, with late-stage studies ongoing in atypical hemolytic uremic syndrome and generalized myasthenia gravis, expected to read out later this year and next year.
This writeup was produced by pharmadog from original reporting by BioSpace.
Original headline: “Novartis ends mid-stage Fabhalta study in lupus, insists no efficacy or safety issues”
read at BioSpace ↗
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