The European Medicines Agency’s (EMA) human medicines committee has recommended the approval of 13 new medicines for use in the European Union. The medicines, which include treatments for rare genetic disorders, cancer, and infectious diseases, were approved after a thorough review by the EMA’s safety and efficacy committees.
Among the newly approved medicines are Aqneursa, used to treat Niemann-Pick type C, a rare genetic disorder; Ekterly, used to treat hereditary angioedema, a rare condition characterized by recurring swelling; and Yeytuo, used as pre-exposure prophylaxis for HIV-1.
Other newly approved medicines include Voranigo, used to treat low-grade astrocytoma or oligodendroglioma, two rare brain tumors; Zurzuvae, used to treat postpartum depression in adults; and Usrenty, used to treat Crohn’s disease, plaque psoriasis, and other conditions.
In addition, the EMA has recommended the approval of several biosimilar medicines, including Bildyos, Bilprevda, Eyluxvi, and Usrenty. Biosimilar medicines are generic versions of existing medications that have been shown to be safe and effective in clinical trials.
The EMA has also approved several new generic medicines, including Macitentan Accord and Macitentan AccordPharma, which will be used to treat pulmonary arterial hypertension.
Source: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-july-2025