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Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)
Shots:
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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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.