Домой Здоровье Перепрофилирование лекарственных препаратов имеет большой потенциал для лечения редких заболеваний

Перепрофилирование лекарственных препаратов имеет большой потенциал для лечения редких заболеваний

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Перепрофилирование лекарственных препаратов имеет большой потенциал для лечения редких заболеваний

Национальный институт здравоохранения США трактует перепрофилирование ЛП следующим образом: «исследование лекарственных препаратов, одобренных для лечения одних заболеваний, на эффективность и безопасность при лечении других заболеваний», пишет Eyeforpharma. Процесс перепрофилирования препарата требует гораздо меньше времени и инвестиций, чем разработка препарата с нуля. Кроме того, перепозиционированные препараты стоят дешевле и доступ к ним шире.

Исторически разработка лекарственных препаратов для лечения редких заболеваний была делом весьма рискованным ввиду небольших целевых популяций пациентов. Принимая во внимание, что разработка нового лекарственного препарата занимает 13–15 лет и обходится компании в среднем в 2–3 млрд долл., с коммерческой точки зрения гораздо выгодней разрабатывать лекарства для более широких категорий пациентов, чтобы окупить расходы.

Чтобы как-то исправить ситуацию, регуляторы США и Европы приняли меры по стимулированию разработки орфанных препаратов. Так, в США в 1983 г. был принят Закон об орфанных лекарственных препаратах (Orphan Drugs Act), а европейские парламентарии в 2000 г. одобрили положение об орфанной продукции медицинского назначения (Regulation № 141/2000). Согласно положениям этих документов, разработчики орфанных препаратов получают определенные льготы и послабления. В частности, более длительный срок патентной защиты, гранты, поддержку регуляторных органов и др.

Результат не замедлил себя ждать. За десять лет до принятия Закона об орфанных лекарственных препаратах в США на рынке появились менее десятка препаратов для лечения редких заболеваний, а в течение последующих 25 лет – более 200. В Европе в 2016 г. было одобрено 14 таких препаратов, а в 2000 г. – всего один.

Несмотря на принятые законы, необходимо больше усилий, направленных на улучшение доступа к орфанным препаратам.

По самым осторожным подсчетам, в настоящее время не существует одобренных препаратов для лечения 95% редких заболеваний (всего зарегистрировано более 7 тыс. редких заболеваний). Перепрофилирование лекарственных средств может значительно снизить это бремя. Пока этим занимаются, в основном, исследовательские институты и некоммерческие организации.

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