The European Medicines Agency issued positive opinions for 104 new medicines in 2025 of which 38 were drugs with new active substances, according to the agency’s annual human medicines report issued on 15 January. At 38, the number is fewer than the 46 novel drugs recommended during the previous year, but no less impactful.
Three of these drugs include Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis; Teizeild (teplizumab) to delay the onset of type 1 diabetes and Zurzuvae (zuranolone), the first oral treatment for postpartum depression. All three of these drugs were also approved by the US Food and Drug Administration which conducts assessments on the basis of its own regulatory guidelines.
Brinsupri is a small molecule inhibitor of the enzyme dipeptidyl peptidase 1 which is responsible for activating inflammatory proteins inside neutrophil white blood cells By blocking the enzyme, the drug reduces airway inflammation and lung damage in people with bronchiectasis, a chronic lung disease.
Teizeild is a monoclonal antibody directed against CD3, a protein complex found on T cells. While the mechanism of action of the drug is not fully understood, Teizeild is thought to deactivate immune cells that mistakenly identify insulin-producing beta cells in the pancreas as foreign.
Zurzuvae (zuranolone) is a small molecule drug that is thought to work in the treatment of postpartum depression by modulating receptors in the central nervous system. The EMA’s positive opinion was based on evidence that the drug could reduce depressive symptoms after two weeks of treatment.
The EMA’s positive opinions must be endorsed by the European Commission before they become legal. This means they are advisory compared with the US where FDA decisions are immediately enforceable. The timing of decisions at both agencies also reflects when a company submits an application. Increasingly the largest companies are submitting applications according to a global commercialisation strategies. This was reflected by announcements in December of an EMA positive opinion and an FDA approval of the drug Exdensur (depemokimab) within five days of each other. The drug was developed by GSK Plc. The EMA recommended approval for severe asthma and chronic rhinosinusitis with nasal polyps. The FDA approved the drug for severe asthma.
Alongside issuing positive opinions for 38 new active substances, the EMA recommended 41 biosimilar drugs for approval. The agency pioneered the regulation of biosimilars which are similar versions of existing biologic drugs. It approved the first biosimilar, Omnitrope (somatropin), a recombinant human growth hormone in 2006.
The agency also assessed three medicines under a regulatory procedure in cooperation with the World Health Organization for countries outside the EU. These were medicines for the treatment of worm parasites and for the prevention of HIV-1 infections.
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