pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2023-11-3-193-210pmedpharm-1353Research ArticleОБЗОРЫREVIEWОбзор лекарственных средств, одобренных FDA в 2022 годуOverview of drugs approved by the FDA in 2022https://orcid.org/0000-0002-1116-3425КуркинД. В.KurkinD. V.

доктор фармацевтических наук, доцент, профессор кафедры клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России; директор научно-образовательного института «Институт фармации им. Н.П. Кравкова», ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1; 

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1.

Doctor of Sciences (Pharmacy), Associate Professor, Professor of the Department of Clinical Pharmacology and Intensive Care, Volgograd State Medical University; Director of the scientific and educational institute “Institute of Pharmacy n.a. N.P. Kravkov" of Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131.

strannik986@mail.ruhttps://orcid.org/0000-0002-7119-3546МорковинЕ. И.MorkovinE. I.

кандидат медицинских наук, доцент, заведующий лабораторией нейропсихофармакологии НЦИЛС ФГБОУ ВО ВолгГМУ Минздрава России

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1.

Candidate of Sciences (Medicine), Associate Professor, Head of the Laboratory of Neuropsychopharmacology, Volgograd State Medical University.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131

e.i.morkovin@gmail.comhttps://orcid.org/0000-0003-4694-3066БакулинД. А.BakulinD. A.

кандидат медицинских наук, старший научный сотрудник лаборатории фармакологии сердечно-сосудистых средств НЦИЛС ФГБОУ ВО ВолгГМУ Минздрава России.

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1.

Candidate of Sciences (Medicine), Senior Researcher, Laboratory of Pharmacology of Cardiovascular Drugs, Volgograd State Medical University.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131

mbfdoc@gmail.comhttps://orcid.org/0000-0002-1116-3425ГорбуноваЮ. В.GorbunovaYu. V.

кандидат фармацевтических наук, доцент кафедры клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России.

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1.

Candidate of Sciences (Pharmacy), Associate Professor, Department of Clinical Pharmacology and Intensive Care, Volgograd State Medical University.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131

yvgorbunova@yandex.ruhttps://orcid.org/0000-0003-1506-2565КолосовЮ. А.KolosovYu. A.

кандидат медицинских наук, доцент, заместитель директора по учебной работе научно-образовательного института «Институт фармации им. Н.П. Кравкова», ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1

 

Candidate of Sciences (Medicine), Associate Professor, Deputy Director for Academic Affairs, of the scientific and educational institute “Institute of Pharmacy n.a. N.P. Kravkov" of Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473

tronk79@gmail.comhttps://orcid.org/0000-0003-2673-6203ДжавахянМ. А.DzhavakhyanM. A.

доктор фармацевтических наук, доцент, главный научный сотрудник, ФГБНУ «Всероссийский научно-исследовательский институт лекарственных и ароматических растений» (ВИЛАР); заместитель директора по разработке и внедрению научно-образовательного института «Институт фармации им. Н.П. Кравкова», ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1.

117216, Россия, г. Москва, ул. Грина, д. 7.

Doctor of Sciences (Pharmacy), Associate Professor, Chief Research Scientist, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants; Deputy Director for development and implementation of the scientific and educational institute “Institute of Pharmacy n.a. N.P. Kravkov" of Yevdokimov Moscow State University of Medicine and Dentistry. 

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473.

7, Grin Str., Moscow, Russia, 117216.

akopovamarina13@mail.ruhttps://orcid.org/0000-0003-2308-0608МакаренкоИ. Е.MakarenkoI. E.

кандидат медицинских наук, руководитель медицинского департамента, ЗАО «Фарм-Холдинг»; научный сотрудник ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1.

198515, Россия, г. Санкт-Петербург, пос. Стрельна, ул. Связи, д. 34-А.

 

Candidate of Sciences (Medicine), Head of the Medical Department of Farm-Holding; Researcher of Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473.

Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, Russia, 198515.

Igor.Makarenko@geropharm.comhttps://orcid.org/0000-0003-4594-6097ДрайР. В.DraiR. V.

кандидат медицинских наук, директор, ЗАО «Фарм-Холдинг».

198515, Россия, г. Санкт-Петербург, пос. Стрельна, ул. Связи, д. 34-А.

 

Candidate of Sciences (Medicine), Director of Farm-Holding.

Bld. A, 34, Svyaz Str., Strelna Vil., St. Petersburg, Russia, 198515

roman.drai@geropharm.comhttps://orcid.org/0000-0002-7923-9916ЗаборовскийА. В.ZaborovskyA. V.

доктор медицинских наук, доцент, заведующий кафедрой фармакологии, ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1.

Doctor of Sciences (Medicine), Associate Professor, Head of the Department of Pharmacology, Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473

azabor@mail.ruhttps://orcid.org/0000-0002-7311-4549ШаталоваО. В.ShatalovaO. V.

доктор медицинских наук, профессор кафедры клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России.

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1.

Doctor of Sciences (Medicine), Professor at the Department of Clinical Pharmacology and Intensive Care, Volgograd State Medical University.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131

shov_med@mail.ruhttps://orcid.org/0000-0002-6997-1601СтрыгинА. В.StryginA. V.

кандидат медицинских наук, доцент, заместитель директора НЦИЛС ФГБОУ ВО ВолгГМУ Минздрава России.

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1

Candidate of Sciences (Medicine), Associate Professor, Deputy Director of Research Center for Innovatie Medicines, Volgograd State Medical University.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131

drumsav@mail.ruhttps://orcid.org/0000-0002-0258-4092ПетровВ. И.PetrovV. I.

доктор медицинских наук, профессор, академик РАН, заведующий кафедрой клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России; директор НЦИЛС ВолгГМУ, главный внештатный специалист–клинический фармаколог Министерства здравоохранения РФ, заслуженный деятель науки РФ, заслуженный врач РФ.

400131, Россия, г. Волгоград, пл. Павших Борцов, д. 1.

Doctor of Sciences (Medicine), Professor, Academician of Russian Academy of Sciences, Head of the Department of Clinical Pharmacology and Intensive Care, Director of Research Center for Innovative Medicines, Volgograd State Medical University; Chief Freelance Specialist, Clinical Pharmacologist of the Ministry of Healthcare of the Russian Federation, Honored Scientist of the Russian Federation, Honored Doctor of the Russian Federation.

1, Pavshikh Bortsov Sq., Volgograd, Russia, 400131

brain@sprintnet.ruhttps://orcid.org/0000-0003-4991-2150ПлетеньА. П.PletenA. P.

доктор биологических наук, профессор кафедры биологической химии ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1.

Doctor of Sciences (Biology), Professor of the Department of Biological Chemistry of Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473

pleatol@mail.ruhttps://orcid.org/0000-0003-0099-3690ПрокоповА. А.ProkopovA. A.

доктор химических наук, доцент, заведующий кафедрой общей и биоорганической химии ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1.

Doctor of Sciences (Chemistry), Associate Professor, Head of the Department of General and Bioorganic Chemistry of Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473

pral@mail.ruhttps://orcid.org/0009-0000-8569-9209Татаренко-КозминаТ. Ю.Tatarenko-KozminaT. Yu.

доктор биологических наук, профессор, заведующий кафедрой медицинской биологии с основами клеточной и молекулярной биотехнологии НОИ «Клиническая медицина им. Н.А. Семашко», ФГБОУ ВО МГМСУ им. А.И. Евдокимова Минздрава России.

127473, Россия, г. Москва, ул. Делегатская, д. 20/1

Doctor of Sciences (Biology), Professor, Head of the Department of Medical Biology with the Fundamentals of Cellular and Molecular Biotechnology, Scientific Research Institute “Clinical Medicine n.a. N.A. Semashko”, Yevdokimov Moscow State University of Medicine and Dentistry.

Bld. 1, 20, Delegatskaya Str., Moscow, Russia 127473

kosmtina025@gmail.com1. Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный медико-стоматологический университет имени А.И. Евдокимова» Министерства здравоохранения Российской Федерации; 2. Федеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.Россия1.Yevdokimov Moscow State University of Medicine and Dentistry. 2.Volgograd State Medical University.Russian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской ФедерацииРоссияVolgograd State Medical UniversityRussian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный медико-стоматологический университет имени А.И. Евдокимова» Министерства здравоохранения Российской ФедерацииРоссияYevdokimov Moscow State University of Medicine and DentistryRussian Federation1. Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный медико-стоматологический университет имени А.И. Евдокимова» Министерства здравоохранения Российской Федерации; 2. Федеральное государственное бюджетное научное учреждение «Всероссийский научно-исследовательский институт лекарственных и ароматических растений» (ВИЛАР).Россия1.Yevdokimov Moscow State University of Medicine and Dentistry. 2.All-Russian Scientific Research Institute of Medicinal and Aromatic Plants.Russian Federation1. Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный медико-стоматологический университет имени А.И. Евдокимова» Министерства здравоохранения Российской Федерации. 2.Закрытое акционерное общество «Фарм-Холдинг».Россия1.Yevdokimov Moscow State University of Medicine and Dentistry. 2.Farm-HoldingRussian FederationЗакрытое акционерное общество «Фарм-Холдинг»РоссияFarm-HoldingRussian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.РоссияVolgograd State Medical UniversityRussian Federation202320112023113193210Copyright © Куркин Д.В., Морковин Е.И., Бакулин Д.А., Горбунова Ю.В., Колосов Ю.А., Джавахян М.А., Макаренко И.Е., Драй Р.В., Заборовский А.В., Шаталова О.В., Стрыгин А.В., Петров В.И., Плетень А.П., Прокопов А.А., Татаренко-Козмина Т.Ю., 20232023Куркин Д.В., Морковин Е.И., Бакулин Д.А., Горбунова Ю.В., Колосов Ю.А., Джавахян М.А., Макаренко И.Е., Драй Р.В., Заборовский А.В., Шаталова О.В., Стрыгин А.В., Петров В.И., Плетень А.П., Прокопов А.А., Татаренко-Козмина Т.Ю.Kurkin D.V., Morkovin E.I., Bakulin D.A., Gorbunova Y.V., Kolosov Y.A., Dzhavakhyan M.A., Makarenko I.E., Drai R.V., Zaborovsky A.V., Shatalova O.V., Strygin A.V., Petrov V.I., Pleten A.P., Prokopov A.A., Tatarenko-Kozmina T.Y.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/1353Цель

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

Материалы и методы

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

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

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.

The aim of the work is to conduct a review of medications approved by the FDA in 2022.

Materials and methods

Materials and methods. In searching for the materials to write this review article, bibliographic databases including PubMed, Google Scholar and e-library.ru were utilized. The search was conducted for the publications spanning the period from 2008 to 2023. Herewith, the following keywords and word combinations were used: new drug approval, NDA, drug authorization, approval package, breakthrough medicine.

Results

Results. The discovery and development of medications are among the most crucial scientific processes in healthcare. Developing a new drug is a highly intricate, expensive, and time-consuming process. Nowadays, the problem of costs reduction and the process of expedited discovering of new medications are particularly pertinent. To optimize the search for active compounds, virtual and high-throughput screenings, machine learning, artificial intelligence, cryo-electron microscopy, and drug repurposing are employed. Simultaneously, the search for original molecules to serve as the basis for innovative drugs continues. This article presents a review of medications approved by the FDA in 2022 for the treatment of various pathologies.

Conclusion

Conclusion. A drug development is a complex and resource-intensive process, with only a small fraction of candidates advancing to clinical trials. A drug design evolves in tandem with societal needs, and this review highlights some of the medications approved by the FDA in 2022. Technological advancements are expected to expedite drug development, potentially reducing the time to the market. Biotechnology, including cell therapy, holds significant prospects, and achievements in genetic mapping and chip technologies will enhance the accessibility of personalized pharmacology.

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The authors declare that there are no conflicts of interest present.