Novartis 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, and Novartis completed the first part, which used complete renal response at week 24 as the primary endpoint, but decided not to proceed with the second part. Iptacopan trials in other indications, including atypical hemolytic uremic syndrome and generalized myasthenia gravis, will continue as planned, and Novartis remains active in lupus nephritis research through the investigational Phase 3 monoclonal antibody ianalumab.