Fot. prof. Ireny Waleckiej na pierwszej stronie artykułu – Monika Szałek
ABSTRACT
New active substances for treating skin diseases: An overview of EMA and FDA approvals (2023-2025)
In recent years, a dynamic development of targeted therapies has been observed in dermatology, driven by an increasingly advanced understanding of the immune and molecular mechanisms underlying skin diseases. The years 2023-2025 brought a number of significant regulatory decisions by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), approving both new active substances and additional indications for previously known drugs. This review provides a summary of skin drug approvals issued during this period, with particular emphasis on the mechanisms of action, clinical efficacy and safety profiles. The active substances in question are used for treating atopic dermatitis, plaque psoriasis, alopecia areata, vitiligo, chronic spontaneous urticaria, prurigo nodularis, hidradenitis suppurativa, and bullous pemphigoid. The presented data confirm the growing role of targeted therapies in dermatology and indicate a substantial expansion of therapeutic options that enables a more effective and safer management of skin diseases and an improvement in the patient’s quality of life.
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