Катрен Стиль
Препарат от гемофилии стал самым дорогим ЛС в мире
Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA) одобрило применение разработанного компанией CSL Behring препарата Hemgenix (etranacogene dezaparvovec), предназначенного для терапии гемофилии типа B. Новое ЛС стало самым дорогостоящим лекарственным средством, одобренным для медицинского применения.
Препарат представляет из себя вирусный вектор, несущий ген фактора IX. Он экспрессируется в печени и производит соответствующий фермент, повышающий уровень фактора IX в крови. Таким образом сокращаются спонтанные кровоизлияния. Схема лечения предполагает одноразовое введение препарата внутривенно.
Клинические испытания ЛС показали его возможность на 54 % снижать частоту преждевременных кровотечений и способность организма вырабатывать фактор IX, ответственный за свёртываемость крови.
Стоимость Hemgenix составляет 3,5 миллиона долларов за одну дозу — это более 210 миллионов рублей по актуальному курсу. Таким образом, в настоящий момент это самый дорогой лекарственный препарат, официально разрешённый к применению. В России Hemgenix не зарегистрирован.
Ранее самым дорогим лекарственным средством в мире считался препарат для лечения спинальной мышечной атрофии «Золгенсма». Стоимость одноразовой терапии этим ЛС превышает два миллиона долларов. В середине ноября директор Федерального центра мозга и нейротехнологий ФМБА РФ Всеволод Белоусов заявил, что в российские технологии позволяют создать более дешёвый аналог «Золгенсмы» в течение двух лет, если от правительства «будет дан зелёный свет».
1 декабря 2022
Фото: © IgorVetushko / Фотобанк Фотодженика
Выпуск: №228, декабрь 2022887 просмотров
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