EMA last report
EMA annual report 2024
Key achievements in 2024
The first chapter focuses on EMA’s strategic priorities and contributions to public and animal health in Europe. Click on the links below to learn more about the most important highlights in the evaluation and monitoring of human and veterinary medicines and major achievements in 2024.
Human medicines
Medicines recommended for approval
The authorisation of new medicines is essential to advancing public health as they bring new opportunities to treat or prevent certain diseases. In 2024, EMA recommended 114 medicines for marketing authorisation, including 46 with new active substances. The medicines recommended for approval in 2024 selected in this overview represent significant progress in their therapeutic areas:
Winrevair, a treatment for adults with pulmonary arterial hypertension, a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs.
Beqvez, a gene therapy treatment for haemophilia B, a rare inherited bleeding disorder.
Emblaveo, an antibiotic for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria resistant to many current treatments for patients.
Emcitate, the first treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome, a rare, chronic and severely debilitating disease caused by mutations in the gene coding for the thyroid hormone transporter MCT8 protein.
Eurneffy, the first nasal spray emergency treatment against allergic reactions, providing an alternative to traditional injections.
Fabhalta, an oral treatment for adults with paroxysmal nocturnal haemoglobinuria, a rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells by the immune system.
Ixchiq, the EU’s first Chikungunya vaccine for adults. Chikungunya is endemic in many (sub)tropical countries and causes recurrent epidemics. Due to climate change, it may also spread to regions so far spared. Ixchiq was assessed under EMA’s OPEN initiative that fosters international collaboration and the sharing of scientific expertise to promote global public health.
Qalsody, a new therapy for the treatment of adult patients with amyotrophic lateral sclerosis (ALS), a rare and often fatal disease that causes muscles to become weak and leads to paralysis. This medicine is indicated for the treatment of adults with ALS, who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Leqembi, a treatment of mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E.
Voydeya, the first oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria.
Welireg, for the treatment of tumours associated with von Hippel-Lindau disease and advanced clear cell renal cell carcinoma. This is the first medicine to treat von Hippel-Lindau disease, a rare genetic disorder causing cysts and tumours.
