Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review - PubMed
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- #drug approvals
- #first-in-class
- #pharmaceutical innovation
- 46 novel drugs were approved in 2025, fewer than in 2024 (53) and 2023 (70).
- 54% of the novel drugs are first-in-class (FIC).
- Approximately 25% of the novel drugs are proteins/antibodies, continuing an industry trend.
- Fewer than half of the novel medicines target major or common disorders.
- Notable FIC drugs include suzetrigine (Nav1.8 channel inhibitor for acute pain), acoltremon (TRPM8 modulator for dry eye disease), lerodalcibep (PCSK9 inhibitor for elevated LDL-c), and zoliflodacin/gepotidacin (bacterial topoisomerase inhibitors for UTIs).
- 41% of the novel drugs target orphan indications.
- Innovative approaches include combining FIC drugs (e.g., avutometinib and defactinib for ovarian cancer), RNAi therapy (fitusiran for haemophilia), and protease inhibition (brensocatib for bronchiectasis).
- Pharmaceutical innovation in 2025 focused on FIC mechanisms, sophisticated therapeutic approaches, and unmet medical needs.