Shots:
- Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)
- Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue per FACIT-Fatigue score (+4.88 at Day 84 & +4.29 at Day 168), along with sustained intravascular hemolysis control & resolved extravascular hemolysis per lactate dehydrogenase levels (<1.5 upper limit of normal) & reduced reticulocyte count
- Additionally, longer-term P-III trial data from APPLY-PNH (vs eculizumab or ravulizumab) & APPOINT-PNH will be presented at EHA 2025
Ref: Novartis | Image: Novartis| Press Release
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