THE European Medicines Agency (EMA) has released an overview of the 2025 key outcomes, with 104 new medicines recommended for approval, of which 38 had a new active substance.
Actives not previously authorised in the European Union (EU) included medicines representing important innovation or contribution to public health, such as the first medicine to treat non-cystic fibrosis bronchiectasis (Brinsupri, brensocatib), a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in children and adults (Teizeild, teplizumab), and the first oral medicine to treat postpartum depression following childbirth (Zurzuvae, zuranolone).
The agency also recommended 16 medicines for rare diseases, including the first medicine (Waskyra, etuvetidigene autotemcel) to treat Wiskott-Aldrich syndrome, a rare, inherited disease of the immune system that affects almost exclusively males.
Another rare disease set to benefit from new treatment is dystrophic epidermolysis bullosa, a condition that makes the skin very fragile, with disease-modifying gene therapy Vyjuvek (beremagene geperpavec) applied as a topical gel to treat wounds.
Biosimilars also featured strongly, with a record 41 recommendations for new products.
Of these, 23 contain denosumab, a monoclonal antibody used to treat bone-related endocrinological conditions such as osteoporosis, bone loss and other skeletal events.
EMA recommendations are submitted to the European Commission for authorisation.
Read the report HERE.
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