The European Medicines Agency released its first data on the activities performed in 2024. Recommendations for marketing authorisation refer to 114 medicines, 46 based on new active substances never authorised before in the EU. Six products received the PRIME designation, and 15 were designed as orphan medicines. EMA also issued five negative opinions, and recommended the approval of one ATMP. Four products were approved under exceptional circumstances; EMA performed three accelerated assessments and eight conditional marketing approvals. The year closed with 8 withdrawn applications.
Among the more innovative products are the first medicine to treat early Alzheimer’s disease (Leqembi – lecanemab), the first needle-free, nasal spray form of adrenaline to treat allergic reactions (Eurneffy – epinephrine), the first treatment for tumours associated with von Hippel-Lindau disease (Welireg – belzutifan), and two new antibiotic medicines (Emblaveo – aztreonam/avibactam). As for new vaccines, 2024 saw the recommendation for approval of the one against Chikungunya disease and a new mRNA vaccine against infections by respiratory syncytial virus (RSV). Oncology represented again the therapeutic area with more recommendations for approval (28), together with the biosimilar products (28).
Source: EMA