Novartis : Phase III Trial Results Show Sustained Efficacy & Long-term Safety Of Fabhalta In PNH

(RTTNews) - Novartis (NVS) said it will present new 48-week results from Phase III APPLY-PNH trial of Fabhalta (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria at the 65th American Society of Hematology Annual Meeting & Exposition or ASH.

The extension data showed that continuous Fabhalta (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled the sustained hemoglobin-level increases to near-normal (=12 g/dL), blood transfusion avoidance, and improved patient-reported fatigue in the majority of patients, with a safety profile consistent with previously reported data.

The company noted that patients switching from anti-C5s to Fabhalta in the extension period achieved outcomes comparable to the Fabhalta arm in the 24-week randomized controlled period, including transfusion avoidance and near-normal hemoglobin-levels (=12 g/dL) in the majority of patients.

Fabhalta was recently approved by the FDA for adults with paroxysmal nocturnal hemoglobinuria, including for both previously treated and treatment-naive patients.

Paroxysmal nocturnal hemoglobinuria is a rare, chronic, and serious complement-mediated blood disorder in which a large proportion of patients can remain anemic and some dependent on blood transfusions despite currently available standard of care, anti-C5 treatments.

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