Core Viewpoint - Novo Nordisk announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending an update to the Alhemo® (concizumab) label to include treatment for severe haemophilia A and moderate or severe haemophilia B without inhibitors [1][4]. Company Overview - Novo Nordisk is a leading global healthcare company founded in 1923, headquartered in Denmark, focusing on chronic diseases, particularly diabetes, and employs approximately 77,400 people across 80 countries [9]. Product Information - Alhemo® (concizumab) is an anti-tissue factor pathway inhibitor designed to block a protein that prevents blood clotting, thus facilitating thrombin production to help clot blood and prevent bleeding [5]. - Currently, Alhemo® is approved in multiple countries, including Europe, the United States, India, Brazil, and Switzerland, for patients with haemophilia A and B with inhibitors, and in Japan and Australia for both with and without inhibitors [5]. Clinical Trial Results - The positive CHMP opinion is based on the phase 3 explorer8 trial, which demonstrated that Alhemo® prophylaxis led to an 86% reduction in treated spontaneous bleeds and a 79% reduction in traumatic bleeds for patients with haemophilia A and B without inhibitors, respectively [2][7]. - Patient-Reported Outcome (PRO) data indicated improvements in health-related quality of life and reduced treatment burden with Alhemo® compared to no prophylaxis, with 70.9% of respondents preferring Alhemo® over previous treatments [3]. Regulatory Expectations - Following the positive opinion from the CHMP, Novo Nordisk anticipates that the European Commission will approve the label update within approximately two months, making Alhemo® available to all patients aged 12 and older with severe haemophilia A and moderate or severe haemophilia B without inhibitors [4][7].