Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)
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The opinion was based on the P-III (APPLY-PNH) & (APPOINT-PNH) trials of Fabhalta (200mg, oral, BID) in PNH patients with residual anemia who switched from Anti-C5 and complement inhibitor naïve (incl. anti-C5 therapies) respectively for 24wks.
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In the APPLY-PNH study, 82.3% vs 2.0% had a ≥2 g/dL increase in Hb levels without transfusions while in APPOINT-PNH, 92.2% of complement inhibitor-naïve Fabhalta patients reached the same
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The transfusion avoidance rate of 94.8% vs 25.9% was observed in APPLY-PNH study. Fabhalta controlled IVH with mean LDH levels <1.5 x upper limit of normal and patients experienced fatigue improvements based on FACIT-F scores
Ref: Novartis | Image: Novartis
Related News:- Novartis Reports Data from the P-III Study of Fabhalta (iptacopan) for the Treatment of IgA Nephropathy (IgAN)
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