默克 ENFLONSIA 获欧盟 CHMP 积极意见：拟扩至24个月以下高风险儿童的第二个 RSV 季
默克（Merck，在美国与加拿大以外称 MSD）11月13日宣布，欧洲药品管理局人用药品委员会（CHMP）已通过积极意见，建议扩大 ENFLONSIA（clesrovimab）的上市许可，把适用人群扩到24个月以下、在第二个呼吸道合胞病毒（RSV）季仍易受严重 RSV 疾病影响的儿童。该建议现送欧盟委员会审议，决定将适用于欧盟、冰岛、列支敦士登与挪威。ENFLONSIA 是一种长效单克隆抗体，用于预防 RSV 下呼吸道疾病，给药剂量不按体重计算。
这一意见的依据是三期 SMART 试验（MK-1654-007）。该试验入组的是重症 RSV 风险较高的婴幼儿，包括早期与中期早产儿、患早产儿慢性肺病或血流动力学显著的先天性心脏病的儿童，并与帕利珠单抗作对照。在第二个 RSV 季，276名符合条件的两岁以下儿童接受了额外一剂210毫克 ENFLONSIA，其安全性与第一个 RSV 季接受该药的婴儿总体一致，体内抗体水平与关键 CLEVER 试验中健康婴儿的水平相近，研究结果支持把疗效外推到这一高风险人群。
ENFLONSIA 已于2025年6月获美国食品药品管理局（FDA）批准、2026年4月获欧盟委员会批准，用于在第一个 RSV 季出生或进入第一个 RSV 季的婴儿，目前已在包括美国、加拿大、欧盟、中国与日本在内的40多个国家获批。美国 FDA 已受理把适应证扩到第二个 RSV 季的补充申请，目标行动日期为2027年3月22日；欧洲药品管理局也已于2026年7月受理欧盟的同一扩围申请，本次 CHMP 积极意见是这项申请的下一步。
Merck's ENFLONSIA Wins Positive EU CHMP Opinion to Expand to Vulnerable Children Up to 24 Months Through Their Second RSV Season
Merck, known as MSD outside the United States and Canada, announced on November 13 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that the marketing authorization for ENFLONSIA (clesrovimab) be expanded to include children up to 24 months of age who remain vulnerable to severe respiratory syncytial virus (RSV) disease through their second RSV season. The recommendation will now be reviewed by the European Commission, whose decision would apply across the European Union, Iceland, Liechtenstein and Norway. ENFLONSIA is a long-acting monoclonal antibody for the prevention of RSV lower respiratory tract disease, administered using the same dose regardless of weight.
The opinion is supported by the Phase 3 SMART trial (MK-1654-007), which enrolled infants and children at increased risk for severe RSV disease, including early and moderate preterm infants and children with chronic lung disease of prematurity or hemodynamically significant congenital heart disease, and compared ENFLONSIA with palivizumab. In the second RSV season, 276 eligible children under two years of age received an additional 210 mg dose of ENFLONSIA. Its safety was generally consistent with that observed in infants who received ENFLONSIA during their first RSV season, and antibody levels were similar to those in healthy infants in the pivotal CLEVER trial, supporting extrapolation of efficacy to this higher-risk population.
ENFLONSIA was approved by the U.S. Food and Drug Administration in June 2025 and by the European Commission in April 2026 for infants born during or entering their first RSV season, and it is now approved in more than 40 countries, including the United States, Canada, the European Union, China and Japan. The FDA has accepted a supplemental application for the same second-season expansion, with a target action date of March 22, 2027, and the European Medicines Agency accepted the EU application in July 2026. The CHMP positive opinion is the next step in that EU review.
来源：默克
发布：GSM·美国（发布链接）
图片来源：图：位于 South San Francisco 的默克研究实验室。Coolcaesar 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Photo: Merck Research Laboratories in South San Francisco, California. Photo by Coolcaesar, CC BY-SA 4.0, via Wikimedia Commons.
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