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]. Group 1: Product Information - Alhemo (concizumab) is an anti-tissue factor pathway inhibitor designed to block a protein that prevents blood clotting, thus promoting 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]. - The product is administered via a user-friendly, pre-filled, portable pen, which is expected to enhance patient adherence and treatment flexibility [2][7]. Group 2: Clinical Trial Results - The positive CHMP opinion is based on the phase 3 explorer8 trial, which demonstrated that Alhemo prophylaxis resulted in 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 a reduction in treatment burden, with 70.9% of respondents preferring Alhemo over previous treatments [3][6]. Group 3: Regulatory Outlook - Following the positive opinion from the CHMP, Novo Nordisk anticipates that the European Commission will approve the label update within approximately two months [4][7]. - If approved, Alhemo will be available to all adult and pediatric patients aged 12 years and older living with severe haemophilia A and moderate or severe haemophilia B without inhibitors [7].