5 February 2019 07:00 GMT
First EMA PRIME eligibility for AstraZeneca
入选资格基于评估MEDI8897安全性和有效性的IIb期临床试验的阳性初步分析
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，欧洲药品管理局(EMA)已批准MEDI8897的PRIME优先药品(PRIME PRIority Medicines)计划, 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).
The PRIME initiative, launched by the EMA in 2016, offers early, 积极和加强对有前景药物开发商的支持，以优化开发计划和加快评估，使这些药物能够更快地到达患者手中. To be eligible for PRIME, 药物必须针对未满足的医疗需求，并根据早期临床数据显示对患者的潜在益处.
Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: “We are excited to receive PRIME eligibility for MEDI8897, 澳门葡京赌博游戏的下一代针对婴儿呼吸道合胞病毒的单克隆抗体. 澳门葡京赌博游戏将与欧洲药品管理局密切合作，优化澳门葡京赌博游戏的开发计划，并帮助澳门葡京赌博游戏尽快将MEDI8897带给患者.”
这是澳门葡京网赌游戏自该项目启动以来获得的首个EMA PRIME资格. It is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, 符合其主要终点定义，即在健康早产儿给药后150天内，由逆转录酶聚合酶链反应证实的RSV引起的医疗护理LRTI发生率有统计学显著降低. 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)，该药物在欧盟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. 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 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 在欧盟，目前有一种批准用于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意义重大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 ngskmc-eis.net 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.