New Phase IIIb data show Novartis Fabhalta improved hemoglobin levels
Novartis (NOVN: VX) today announced positive top-line results from APPULSE-PNH, a Phase IIIb study on the efficacy and safety of twice-daily oral monotherapy Fabhalta(iptacopan).
The study evaluated adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were switched from anti-C5 therapies (Hb ≥10g/dL following treatment with eculizumab or ravulizumab). After 24 weeks of treatment with Fabhalta, the average Hb level improved versus baseline, the Swiss pharma giant noted.
In the study, the safety profile of Fabhalta monotherapy was consistent with previously reported data, the company noted.
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