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

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

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  • 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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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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