Review of medicines approved by the Food and Drug Administration from 2012 to 2024

The aim. To describe the key characteristics of medical products approved by the Food and Drug Administration (FDA) and released by pharmaceutical companies from 2012 to 2024.

Materials and methods. The analysis is based on data from FDA publications related to the approval of medical products from 2012 to 2024. The products were systematized by year, pathway and reason for approval, nature of the active substance (synthetic, semi-synthetic, natural or biological) and target disease (indication for use) in accordance with the codes of the Anatomical Therapeutic Chemical (ATC) classification.

Results. During the analyzed period, the FDA approved a significant number of medicines, while maintaining a stable proportion of small molecules with a significant upward trend in the number of approved biologicals (monoclonal antibodies, CAR-T, siRNA, gene therapy, etc.). The largest proportion was accounted for by antitumor drugs and immunomodulators (group L according to ATC), demonstrating steady growth with projected growth in the future. Interest in drugs for the treatment of metabolic disorders and diseases of the nervous system remained steadily high, with the emergence of innovative therapeutic approaches. A gradual increase in the number of repositionings and extensions of indications was noted. The COVID-19 pandemic did not have a significant impact on the overall structure of approvals, and only two specific medicines for the treatment of COVID-19 were approved. There has been an increase in approvals for orphan diseases and the emergence of innovative therapeutic approaches: gene therapy, RNA interference, cell technologies, and bispecific antibodies.

Conclusion. In the period from 2012 to 2024, the pharmaceutical industry has seen a fundamental shift towards biotechnological development methods, personalized medicine, and targeted therapy. During the period under review, the proportion of small molecule approvals remained fairly stable, but a steady (compared to previous periods) increase in the number of biotechnology product approvals (monoclonal antibodies, gene and RNA therapy) can be noted. The largest increase was noted in class L (antitumor drugs and immunomodulators), which reflects the focus of global pharmaceutical companies on the fundamental study and discovery of pharmacotherapy opportunities in the oncology and immunity. It is necessary to note the trend towards the development of drugs for the treatment of rare (orphan) diseases. In the field of therapy for metabolic disorders, during the specified period, drugs were approved that revolutionized understanding of an entire cluster of diseases and approaches to therapy, and a new standard of therapy was formed due to SGLT2 inhibitors and agonists of the incretin system receptors, including molecules with a multi-targeted effect. The COVID-19 pandemic led to a limited number of drug approvals for the treatment of this infection but thanks to it, the “door” to the development of new generation vaccines has been opened, which are largely fundamentally different from those currently existing. The discovery of new means to combat infectious agents of various nature (bacteria, protozoa, viruses, fungi, and parasites) is also one of the priority goals of pharmaceutical companies, as evidenced by a significant proportion of approvals of drugs with a similar effect. In terms of “reasons for registration,” the main share fell on original drugs; the contribution of new combinations and dosage forms was at its peak in the middle of the period and then decreased. Due to the expiration of patent protection for many drugs and the accumulation of data on their effects in the post-marketing period, a gradual increase in the number of repositionings and extensions of indications can be logically noted.

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