"Vonicog alfa"

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                            1
                            2024European Medicines Agency - EPARs
                            Vonicog alfa (Veyvondi) - von Willebrand disease 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged. EMA/478238/2023 EMEA/H/C/004454 Veyvondi (vonicog alfa) An overview of Veyvondi and why it is authorised in the EU What is Veyvondi and what is it used for? Veyvondi is a medicine used to control bleeding in adults with von Willebrand disease (an inherited bleeding disorder) who cannot be treated with desmopressin (another medicine to stop bleedings) or in whom desmopressin does not work. It is used to prevent and treat bleeding
                            2
                            2022All Wales Medicines Strategy Group
                            Vonicog alfa (Veyvondi) - von Willebrand disease Prepared by the All Wales Therapeutics and Toxicology Centre Page 1 of 5 Vonicog alfa (Veyvondi®▼) for on-demand treatment of non-surgical and surgical (elective and emergency) bleeding episodes in children aged up to 17 years with von Willebrand disease (OW19) November 2022 ONE WALES INTERIM DECISION Vonicog alfa (Veyvondi®▼) for on-demand treatment of non-surgical and surgical (elective and emergency) bleeding episodes in children aged up to 17 years with von Willebrand disease Date of advice: November 2022 The following One Wales Medicines Assessment Group (OWMAG) recommendation has been endorsed by health board Chief Executives. Using the agreed starting and stopping criteria, vonicog alfa (Veyvondi®▼) can be made available within
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                            3
                            2020INESSS (Quebec)
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                            Vonvendi (vonicog alfa) recombinant von Willebrand factor – von willebrand disease 1 VonvendiMC (vonicog alfa) Recombinant von Willebrand factor – von Willebrand disease Une production de l’Institut national d’excellence en santé et en services sociaux (INESSS) Direction des services de santé et de l’évaluation des technologies JANVIER 2020 1 SUMMARY Vonvendi™ (vonicog alfa) Recombinant von Willebrand factor – von Willebrand disease Mandate The Institut national d’excellence en santé et en services sociaux (INESSS) evaluated the blood system product Vonvendi™ (vonicog alfa, BAX 111), an intravenously injected recombinant von Willebrand factor (rVWF) for the treatment and control of bleeding episodes and the perioperative management of bleeding in adults (age ≥ 18) diagnosed
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                            2016Health Technology Assessment (HTA) Database.
                            Review Analysis
                            Appears Promising
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                            Vonicog alfa for severe von Willebrand disease Vonicog alfa for severe von Willebrand disease ..
                            5
                            2024NIHR Innovation Observatory
                            thrombocytopeniaNovember 2023 Technology Briefings Marstacimab for the treatment of haemophilia A and haemophilia BJune 2023 Technology Briefings Giroctocogene fitelparvovec for haemophilia AMarch 2023 Technology Briefings Ravulizumab for treating thrombotic microangiopathies following haematopoietic stem cell transplantation in childrenFeburary 2023 Technology Briefings Vonicog alfa for Prophylaxis of Haemorrhage
                            6
                            2025Blood
                            Enhanced α2-3 linked sialylation determines the extended half-life of CHO-rVWF. The half-life of recombinant VWF (rVWF) expressed in CHO cells (CHO-rVWF; Vonicog alfa, VonvendiÒ / VeyvondiÒ) is significantly longer than plasma-derived (pd) VWF concentrates. This finding is intriguing since CHO cells do not generate α2-6 sialylation, which constitutes the majority of human pdVWF sialylation. We
                            7
                            2022Blood
                            Recombinant von Willebrand factor prophylaxis in patients with severe von Willebrand disease: phase 3 study results. International guidelines conditionally recommend long-term prophylaxis in patients with von Willebrand disease (VWD) and severe and frequent bleeding. As recombinant von Willebrand factor (rVWF; vonicog alfa) may reduce the frequency of treated spontaneous bleeding events (BEs), we
                            8
                            2024Clinical Trials
                            A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK) This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor [rVWF]). Von Willebrand disease (VWD
                            9
                            2019Clinical Trials
                            A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD) The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study
                            10
                            2012Wikipedia
                            . Infusion of platelet concentrates is recommended for correction of hemorrhage associated with platelet-type VWD.[medical citation needed]Vonicog alfa is a recombinant von Willebrand factor that was approved for use in the United States in December 2015, and for use in the European Union in August 2018.[26][27]Epidemiology[edit]The prevalence of VWD is about one in 100 individuals.[28] However
                            11
                            2016Clinical Trials
                            Eligibility Criteria Contacts and Locations More Information Brief Summary: The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa * vonicog alfa
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                            2015Clinical Trials
                            . Other Names: * vonicog alfa . Other Names: * vonicog alfa