Обзор лекарственных средств, одобренных FDA в 2022 году

Цель. Анализ актуальных тенденций зарубежной практики в области разработки и регистрации лекарственных препаратов.

Материалы и методы. При поиске материала для написания обзорной статьи использовали реферативные базы данных PubMed, Google Scholar и e-library.ru. Поиск осуществляли по публикациям за период с 2008 по 2023 год, с использованием следующих ключевых слов: «new drug approval», «NDA», «drug authorization», «approval package», «breakthrough medicine».

Результаты. Открытие и разработка лекарственных средств являются одними из наиболее важных научных направлений в здравоохранении. Разработка нового препарата – очень сложный, дорогой и длительный процесс. Как снизить затраты и ускорить открытие новых лекарств? Этот вопрос является особенно актуальным на сегодняшний день. Для оптимизации процесса поиска активных соединений используются виртуальный и высокопроизводительный скрининг, машинное обучение, искусственный интеллект, криоэлектронная микроскопия, а также перепрофилирование существующих лекарственных средств. В то же время продолжается поиск оригинальных молекул для разработки на их основе инновационных препаратов. В данной статье представлен обзор лекарственных средств, одобренных в 2022 году Food and Drug Administration (FDA), для лечения различных патологий.

Заключение. Разработка лекарств представляет собой сложный и ресурсоемкий процесс, при котором лишь небольшая часть кандидатов доходит до клинических испытаний. Дизайн лекарств развивается вместе с потребностями общества, и в этом обзоре освещаются некоторые из препаратов, одобренных FDA в 2022 году. Ожидается, что технологические достижения ускорят разработку лекарств, потенциально сокращая время их выхода на рынок. Биотехнология, включая клеточную терапию, имеет большие перспективы, а достижения в области генетического картирования и технологий чипов повысят доступность персонализированной фармакологии.

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