商务合作
动脉网APP
可切换为仅中文
The European Medicines Agency’s priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four VEGF pathway targets (VEGF A, B, C, and PlGF) in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME)Designation follows positive interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile; 4D-150 has the potential to address an unmet medical need to maintain long term visual acuity outcomes while avoiding the need for repeated intravitreal injectionsInterim clinical data from randomized Phase 2 PRISM Dose Expansion clinical trial in highest anti-VEGF need patients (n=50) to be released in early 2024 EMERYVILLE, Calif., Oct.
欧洲药品管理局的优先药品状态授予可能提供优于现有治疗的主要治疗优势的候选药物,或使没有治疗选择的患者受益4D-150结合了一种新颖的,具有抑制湿性年龄相关性黄斑变性(湿性AMD)和糖尿病性黄斑水肿(DME)指定中的四种VEGF途径靶标(VEGF a,B,C和PlGF)的双转基因的靶向玻璃体内下一代AAV载体遵循阳性中期阶段4D-150的1 PRISM临床数据显示出令人鼓舞的安全性,耐受性和临床活性特征;4D-150有可能解决未满足的医疗需求,以维持长期视力结果,同时避免需要重复玻璃体内注射来自最高抗VEGF需求患者的随机2期PRISM剂量扩展临床试验的临床数据(n=50)将于2024年初在加利福尼亚州埃默里维尔发布,10月。
23, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD).
232023(GLOBE NEWSWIRE)-4D Molecular Therapeutics(纳斯达克股票代码:FDMT,4DMT或该公司),一家临床阶段的生物治疗公司,目前正在临床上使用三种新型,高度靶向的下一代AAV载体,今天宣布,欧洲药品管理局(EMA)已为研究性遗传医学候选药物4D-150授予优先医学(PRIME)称号,用于玻璃体内治疗湿性年龄相关性黄斑变性(湿性AMD)。
PRIME designation is granted by the EMA to enhance support for the development of medicines that target an unmet medical need and offers the opportunity to accelerate review of the marketing applications to bring such medicines to patients sooner. The designation follows positive interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and .
EMA授予PRIME称号,以加强对针对未满足医疗需求的药物开发的支持,并提供加速审查营销应用以更快地将此类药物带到患者的机会。该名称遵循4D-150的阳性中期1期PRISM临床数据,证明了令人鼓舞的安全性,耐受性和。