Novartis Reports US FDA’s Approval of Fabhalta (iptacopan) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
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- The approval was based on the P-III (APPLY-PNH) & (APPOINT-PNH) trials evaluating Fabhalta (200mg, oral, BID) vs anti-C5 therapies & Fabhalta alone in PNH patients with residual anemia & those naïve to complement inhibitor (incl. anti-C5 therapies) respectively for 24wks.
- The results depicted that of the patients with a sustained increase of Hb levels ≥2g/dL from baseline in the absence of transfusions, responses were seen in 82.3% vs 0% of patients in (APPLY-PNH) & 77.5% of patients in (APPOINT-PNH) study
- Furthermore, of the patients with a sustained increase of Hb levels ≥12g/dL in the absence of transfusions, responses were seen in 67.7% vs 0% of patients with a transfusion avoidance rate of 95.2% vs 45.7% in the (APPLY-PNH) study
Ref: Novartis | Image: Novartis
Related News:- Novartis Reports Pre-Specified Interim Analysis Results from the P-III Study (APPLAUSE-IgAN) for Iptacopan to Treat IgA Nephropathy
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
