Novartis (NVS) said Thursday that its phase 3b study of Fabhalta in adult patients with paroxysmal nocturnal hemoglobinuria, or PNH, showed "statistically significant and clinically meaningful" improvements in hemoglobin levels.
The trial enrolled 52 patients who received Fabhalta for 24 weeks and the primary endpoint was change from baseline hemoglobin levels, the company said.
Most patients under trial achieved normal or near-normal levels of hemoglobin and no patient required transfusion during the study, Novartis said, adding that patients also reported significant improvements in fatigue.
Novartis shares were up more than 1% in recent premarket activity Thursday.
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