Novartis Reports US FDA's Approval of Fabhalta (iptacopan) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

By PharmaShots

Shots: 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) respective

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