Summary LukoNext has received formal approval from the European Medicines Agency, granting it market authorization in Europe. The approval was based on robust clinical evidence demonstrating rapid mitigation of acute attacks in patients with hereditary angioedema. Following a single dose, symptom relief occurred on average within 30 minutes, and severe adverse events were rarely reported, indicating a favorable safety profile. As a recombinant protein product, it offers high manufacturing efficiency and the potential for cost competitiveness. Although reimbursement across Europe is currently limited, the approval provides a basis for national health authorities to consider coverage, which is expected to improve patient access.