Оригинальные лекарственные препараты, одобренные Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов (Центр оценки и исследований лекарственных средств) в 2025 году

Ежегодный обзор новых препаратов, одобренных FDA, представляет собой важный инструмент для анализа современных тенденций в фармакологии и медицине, отражая прогресс в лечении сложных заболеваний, включая онкологические патологии, орфанные болезни и инфекционные процессы. Статья направлена на информирование медицинских специалистов и фармакологов о современных тенденциях в разработке и регистрации инновационных лекарственных препаратов в 2025 году.

Цель. Обобщить и систематизировать данные о новейших лекарственных препаратах, вышедших на рынок в 2025 году, а также проанализировать механизмы их действия.

Материалы и методы. Представленные данные взяты из открытых источников и дополнены результатами отдельных исследований, посвящённых изучению новых механизмов и подходов в терапии. Основной список новых лекарственных препаратов и вводная информация о них взяты из отчета Управления по санитарному надзору за качеством пищевых продуктов и медикаментов (FDA) — «Novel Drug Approvals for 2025».

Результаты. В 2025 году FDA одобрено 46 лекарственных препаратов, среди которых 31 — это малые молекулы и 15 — макромолекулы. Среди препаратов из первой группы в онкологии применяют 11 (24% от всех новых препаратов и 35% от всех новых малых молекул), 2 — иммунотропные и 2 для применения в кардиологии. Большая часть (16 препаратов) относится к разрозненным группам препаратов. Среди биопрепаратов большую часть составили моноклональные антитела для лечения неонкологических заболеваний — 6 (13% от всех и 40% от биопрепаратов) и моноклональные антитела для лечения онкологических заболеваний — 5 (11% от всех и 33% от биопрепаратов). Препараты на основе нуклеиновых кислот и белковые молекулы, кроме антител, составили 3 (7% от всех и 20% от биопрепаратов) и 1 (2% от всех и 7% от биопрепаратов) соответственно.

Заключение. Большая доля биопрепаратов среди вновь зарегистрированных лекарственных препаратов в 2025 году подчёркивает динамичное развитие фармацевтической отрасли и ее ориентацию на персонализированную медицину и биотехнологии. Терапия, основанная на mAb, взаимодействующих с рецепторами, а также иммунотерапия, основанная на новых открытых механизмах противоопухолевого иммунитета, занимает весомучасть в структуре оригинальных препаратов. Остаётся актуальным поиск новых рациональных комбинаций антибиотиков. Большую часть рынка оригинальных препаратов все еще составляют малые молекулы, среди которых появляются лекарственные средства — лиганды новых мишеней и олигонуклеотидные последовательности. Обзор составлен для ознакомления медицинских специалистов и фармакологов с современными тенденциями в регистрации оригинальных препаратов и в терапии злокачественных образований, а также орфанных болезней.

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