5 February 2019 07:05 GMT
基于IIb期正面初步分析的指定
trial that demonstrated the safety and efficacy of MEDI8897
澳门葡京网赌游戏及其全球生物制剂研发部门, MedImmune, 今天宣布，美国食品和药物管理局(FDA)已授予MEDI8897突破性治疗指定(BTD), 一种延长半衰期的呼吸道合胞病毒(RSV) F单克隆抗体(mAb)正在研制中，用于预防RSV引起的下呼吸道感染(LRTI).
BTD旨在加快旨在治疗严重疾病并已显示出令人鼓舞的早期临床结果的药物的开发和监管审查, 与现有药物相比，哪一种药物可能在临床显著终点上有实质性改善. MEDI8897正在与赛诺菲巴斯德合作开发，并于2015年3月获得美国FDA的快速通道指定.
Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, 他说:“MEDI8897是澳门葡京赌博游戏的下一代呼吸道合胞病毒预防药物, 哪些有可能解决婴儿未满足的重要需求, families and caregivers. The Breakthrough Therapy Designation, 以及其最近获得的欧洲药品管理局PRIME资格, 是否能帮助澳门葡京赌博游戏尽快将MEDI8897带给所有有感染呼吸道合胞病毒风险的婴儿.”
The BTD is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, 满足其主要终点定义为由逆转录酶聚合酶链反应证实的RSV引起的医疗护理LRTI发生率的统计学显著降低, for 150 days after dosing in healthy preterm infants. IIb期临床试验的全部结果将在即将召开的医学会议上公布.
About MEDI8897
MEDI8897是一种延长半衰期的RSV F单抗，用于预防由RSV引起的下呼吸道感染. MEDI8897正在开发中，用于比目前RSV预防护理标准更广泛的婴儿人群, Synagis (帕利珠单抗)，该药物在美国仅被批准用于高危婴儿. Additionally, MEDI8897正在开发中，因此在典型的5个月RSV季节只需要一次剂量, vs. monthly injections with current standard of care.1
MEDI8897的开发计划还包括一项晚期早产儿和健康足月婴儿的III期试验. AstraZeneca will also conduct a Phase II/III study in Synagis-符合条件的儿科患者生成用于该人群的附加数据.
In February 2019, the EMA granted PRIME eligibility to MEDI8897.
In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialise MEDI8897 jointly. In November 2018, AstraZeneca announced 瑞典Orphan Biovitrum AB (public) (Sobi)有权参与MEDI8897可能从美国获得的利润或损失的支付.
About RSV
呼吸道合胞病毒是全世界婴幼儿下呼吸道感染的最常见病因, 90%的儿童在出生后的头两年感染呼吸道合胞病毒. Of those, up to 40% will experience a LRTI with the initial episode, 将开发和提供有效的预防方法作为一项重要的公共卫生优先事项.2 在美国，目前有一种被批准用于RSV预防的药物， Synagis (palivizumab), 适用于高危儿童(胎龄≤35周的早产儿), children with chronic lung disease of prematurity, 以及患有血流动力学显著的慢性心脏病的儿童).3
About MedImmune
MedImmune是澳门葡京网赌游戏的全球生物制剂研发部门, a global, 专注于发现的创新驱动型澳门葡京赌博游戏企业, 小分子和生物处方药的开发和商业化. MedImmune在肿瘤学领域开拓创新研究和探索新途径, Respiratory, Cardiovascular, Renal and Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D个中心，在英国剑桥和加州南旧金山设有额外的站点. For more information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, development and commercialisation of prescription medicines, 主要用于治疗肿瘤等三个治疗领域的疾病, Cardiovascular, Renal & Metabolism and Respiratory. 澳门葡京网赌游戏在100多个国家开展业务，其创新药物被全球数百万患者使用. For more information, please visit mokmingsky.com and follow us on Twitter @AstraZeneca.
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References
1. Domachowske JB, Khan AA, Esser MT, et al. Safety, Tolerability, and Pharmacokinetics of MEDI8897, 延长半衰期单剂量呼吸道合胞病毒预融合f-靶向单克隆抗体单剂量给予健康早产儿. The Pediatric Infectious Disease Journal. September 2018:886-892. doi:10.1097/inf.0000000000001916.
2. Adamko DJ, Friesen M. Why does respiratory syncytial virus appear to cause asthma? Journal of Allergy and Clinical Immunology. 2012;130(1):101-102. doi:10.1016/j.jaci.2012.05.024.
3. Synagis Prescribing Information.