Core Viewpoint - The European Commission has granted orphan drug designation to Viligene (Opalizumab, LBL-024) for the treatment of extra-pulmonary neuroendocrine carcinoma, marking a significant milestone in its global development process after receiving similar recognition from the FDA [1][2]. Group 1 - The orphan drug designation is intended for medicines used to diagnose, prevent, or treat life-threatening or chronically debilitating diseases with a prevalence of less than 5 in 10,000 in the EU [2]. - The designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on research design related to drug quality, benefits, and risks [2]. - The orphan drug status grants a 10-year market exclusivity period in the EU, during which no similar drugs for the same indication can be approved, ensuring protection even without patent coverage [2]. Group 2 - Additional benefits of orphan drug designation include fee reductions for regulatory guidance, marketing authorization applications, and post-marketing changes [2]. - Companies may also access funding from the European Commission, Horizon Europe, and other sources upon receiving orphan drug designation [2]. - Extra incentives are available for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance, as well as fee reductions [2].
维立志博-B(09887)：维利信?用于治疗肺外神经内分泌癌获欧盟委员会授予孤儿药认定（ODD）