Novartis terminates Phase 2 Fabhalta lupus nephritis study, citing strategy
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Novartis has ended a Phase 2 trial of Fabhalta (iptacopan) in lupus nephritis, attributing the decision to strategic considerations rather than efficacy or safety problems. The study had enrolled 81 patients and completed its first part, in which complete renal response at week 24 served as the primary endpoint; Novartis chose not to move forward with the second part. Iptacopan studies in other indications, including atypical hemolytic uremic syndrome and generalized myasthenia gravis, will continue as planned. Novartis also says it remains committed to lupus nephritis research through ianalumab, an investigational Phase 3 monoclonal antibody. No new iptacopan lupus data have been disclosed alongside the termination.
Written by a model from the reports · updated 2 hours ago
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- BioSpacePickNovartis ends mid-stage Fabhalta study in lupus, insists no efficacy or safety issues
Novartis has terminated a Phase 2 study of Fabhalta (iptacopan) in lupus nephritis, saying the decision was based on strategic considerations and not on any efficacy or safety issues. The study enrolled 81 patients; Novartis completed the first part, which had complete renal response at week 24 as its primary endpoint, but decided not to proceed with the second part. Iptacopan trials in other indications such as atypical hemolytic uremic syndrome and generalized myasthenia gravis will continue as planned, and Novartis remains in lupus nephritis with its investigational Phase 3 monoclonal antibody ianalumab.
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