EMA grants PRIME eligibility for potential next-generation RSV medicine MEDI8897

2019年2月5日07:00 GMT
 

澳门葡京网赌游戏首次获得EMA PRIME资格

Eligibility based on positive primary analysis of the ii期临床试验 评价MEDI8897的安全性和有效性
 

澳门葡京网赌游戏 and its global biologics research and development arm, 落实的, today 宣布 that the European 药物 Agency (EMA) has granted access to its PRIME PRIority MEdicines) scheme for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

PRIME计划, 由EMA于2016年推出, 提供了早期, proactive and enhanced support to developers of promising medicines to optimise development plans and accelerate evaluation so these medicines can reach patients faster. 才有资格申请PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.

执行副总裁梅内·潘加罗斯&D澳门葡京赌博游戏, 说:“澳门葡京赌博游戏很高兴收到MEDI8897的PRIME资格, our next-generation monoclonal antibody targeting respiratory syncytial virus in infants. We will work closely with the European 药物 Agency to optimise our development plan and help us bring MEDI8897 to patients as quickly as possible.”

This is the first EMA PRIME eligibility that 澳门葡京网赌游戏 has received since the programme’s initiation. 这是基于对的初步分析 ii期临床试验 评价MEDI8897的安全性和有效性, which met its primary endpoint defined as a statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV for 150 days after dosing in healthy preterm infants. Full results from the ii期临床试验 will be presented at a forthcoming medical meeting.

关于MEDI8897

MEDI8897 is an extended half-life RSV F mAb being developed for the prevention of LRTI caused by RSV. MEDI8897 is being developed for use in a broader infant population than the current standard of care for RSV prevention, Synagis (palivizumab), which in the EU is only approved for use in high-risk infants. 另外, MEDI8897 is being developed so that it may only require one dose during a typical five-month RSV season vs. 按现行护理标准每月注射一次.¹

The development programme for MEDI8897 also includes a Phase III trial in late preterm and healthy full-term infants. 澳门葡京网赌游戏还将进行一项II/III期研究 Synagis-eligible paediatric patients to generate additional data for use in this population.

2017年3月，澳门葡京网赌游戏和赛诺菲巴斯德宣布了一项合作 协议 共同开发和推广MEDI8897. 2018年11月，澳门葡京网赌游戏 宣布 Swedish Orphan Biovitrum AB (publ) (Sobi) has the right to participate in payments that may be received from the US profits or losses for MEDI8897.

对RSV

RSV is the most common cause of LRTI in infants and young children worldwide, and 90% of children are infected with RSV in the first two years of life. 这些, 高达40%的患者会在初始发作时出现下呼吸道感染, making the development and availability of effective prevention methods a critical public health priority.² In the EU, there is currently one approved medicine for RSV prophylaxis, Synagis (palivizumab), indicated for high-risk children (premature infants ≤ 35 weeks gestational age, 早产儿慢性肺病患儿, and children with haemodynamically-significant chronic heart disease).³

关于美

落实的 is the global biologics research and development arm of 澳门葡京网赌游戏, 一个全球, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. 落实的 is pioneering innovative research and exploring novel pathways across 肿瘤学, 呼吸, 心血管, 肾脏和代谢疾病, 感染和疫苗. 落实的总部位于马里兰州的盖瑟斯堡.澳门葡京网赌游戏全球三大研发中心之一&D centres, with additional sites in 剑桥, UK and South San Francisco, CA. 欲了解更多信息，请访问 www.落实的.com.

关于澳门葡京网赌游戏

澳门葡京网赌游戏是一家全球性的, science-led biopharmaceutical company that focuses on the discovery, 处方药的开发和商业化, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 心血管, 肾 & 代谢与呼吸. 澳门葡京网赌游戏 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 欲了解更多信息，请访问 澳门葡京网赌游戏.com 并在推特上关注澳门葡京赌博游戏 @澳门葡京网赌游戏.
 

联系人

艾德里安·坎普
公司秘书
澳门葡京网赌游戏

参考文献

1. Domachowske JB, Khan AA, Esser MT，等. 安全, 耐受性, MEDI8897的药代动力学研究, an Extended Half-Life Single-Dose 呼吸 Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. 儿科传染病杂志. 892年9月2018:886 -. doi: 10.1097 /正.0000000000001916.

2. Adamko DJ, Friesen M. 为什么呼吸道合胞病毒会引起哮喘? 变态反应与临床免疫学杂志. 2012;130(1):101-102. doi: 10.1016/j.jaci.2012.05.024.

3. Synagis 处方信息.