CHMP approves Veyvondi for adult patients with vascular haemophilia aged 18 and over
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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Recently, thePharmaceutical(Corporate(Announced, EuropeanMedicines(EMA)Pharmaceutical(CHMP) has issued a positive opinion recommending the approval of Veyvondi (vo
nicog alfa, recombinant blood The apopathic factor (rVWF) is used in adult patients with vascular haemophilia (VWD) aged 18 years and older, to treat bleeding events and to treat/prevent surgical bleeding when the single use of deamone pressure (DDAVP) to treat hemorrhage is ineffective or not applicableabout vo
nicog alfain the United States, vo
nicog alfa brand name vonvendi, the drug was approved in December 2015 for on-demand treatment and bleeding event control in adult patients with VWDin April, Vonvendi was re-approved by theFDA(approved for perioperative management in adult patients with VWD)To date, Vonvendi remains the first and only FDA-approved rVWF
drug() in the U.Smarket to treat adult patients with VWDCHMP recommended approval of Veyvondi, based on data from 3 clinical studiesA total of 80 VWD patients in these studies received Veyvondi treatment, including a multicenter, controlled, randomized, single-blind, dose-increasing Phase I study, a multicenter, open label Phase III study, a prospective, open label, non-control, non-randomized Phase III studyDeveloped by Baxalta, Vonvendi was acquired by Shire in January 2016 for $32 billion, making it a global leader in the development of rare disease drugs, Shire is also developing Vonvendi as a preventive drug and paediatric indications
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