AstraZeneca’s Voydeya Receives the US FDA’s Approval as an Add-on Therapy to Treat Extravascular Haemolysis in PNH Patients


The US FDA has approved Voydeya as an add-on therapy to ravulizumab or eculizumab for treating extravascular haemolysis (EVH) in adults having paroxysmal nocturnal haemoglobinuria (PNH)
The approval was supported by the P-III (ALPHA) study investigating the safety and efficacy of Voydeya as an add-on treatment to ravulizumab or eculizumab in PNH patients experiencing EVH
The study, at wk.12, showed a change in haemoglobin of 2.94g/dL vs 0.50g/dL from baseline, 59.5% vs 0% of patients had improved haemoglobin of ≥2 g/dL in the absence of transfusion, improvement in transfusion avoidance as well as change in FACIT-Fatigue score. Results were published in The Lancet Haematology


Ref: AstraZeneca | Image: AstraZeneca

Related News:- AstraZeneca’s Voydeya Receives CHMP’s Recommendation for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH) with Residual Haemolytic Anaemia

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