European Medicines Agency approves 12 new drugs and updates COVID‑19 vaccines

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion on twelve new medicines. Highlights include a rechargeable ocular implant delivering ranibizumab for neovascular age‑related macular degeneration, the first oral interleukin‑23 receptor inhibitor icotrokinra for moderate‑to‑severe plaque psoriasis in patients aged 12 and older, and three cholesterol‑lowering agents (lerodalcibep, obicetrapib/ezetimibe, obicetrapib). Other approvals cover linerixibat for cholestatic pruritus in primary biliary cholangitis, the antiviral ensitrelvir for post‑exposure COVID‑19 prophylaxis, a therapy for cerebral adrenoleukodystrophy, a pegfilgrastim biosimilar and generic versions of riociguat, ruxolitinib and tafamidis.

In parallel, the EMA recommended updating the composition of the COVID‑19 vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to improve effectiveness against the emerging XFG variant for the 2026‑2027 vaccination campaign.