Sobi’s Altuvoct Receives the EC’s Marketing Authorization to Treat Haemophilia A
Shots:
- The EC has approved Altuvoct to treat & prevent bleeds and perioperative prophylaxis in haemophilia A and granted ODD, providing it 10yrs. of market exclusivity
- The authorization was supported by two P-III studies, XTEND-1 (n=159; ≥12yrs.) assessing Altuvoct across the prophylaxis arm (52wks.) & on-demand arm (26wks. followed by switching to weekly prophylaxis 26wks. more) & XTEND-Kids (n=74; <12yrs.) assessing prophylactic Altuvoct in previously treated severe haemophilia A patients
- Studies showed that Altuvoct prophylaxis (50 IU/kg, QW) reduced bleeding regardless of age (mean ABR<1, 80-88% bleed-free) as well as improved joint health, physical health, pain & quality of life at 52wks. without factor VIII inhibitors
Ref: Sobi | Image: Sobi
Related News:- Sanofi and Sobi Present P-III Study (XTEND-Kids) Results of Altuviiio for Severe Hemophilia A at ISTH 2023
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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.
