The Food and Drug Administration has cleared a new treatment designed to protect infants from respiratory syncytial virus.

美国食品和药物管理局已经批准了一种旨在保护婴儿免受呼吸道合胞病毒的新疗法。

Called Enflonsia and developed by Merck & Co., the drug is an antibody intended to prevent illness from RSV, which can be particularly severe in young children. It was

名为Enflonsia的药物由默克公司开发，是一种旨在预防RSV（呼吸道合胞病毒）引发疾病的抗体，这种病毒在幼儿中可能特别严重。它被

approved on Monday

周一获批

for newborns and infants who are born during, or ahead of, their first RSV season.

对于在第一个RSV季节期间或之前出生的新生儿和婴儿。

Over the last couple years, the treatment landscape has changed significantly for RSV, a widespread pathogen that causes respiratory illness. Most of that innovation, though, has centered around preventive therapies for older adults, for which RSV infections can prove lethal. There are now three vaccines available from .

过去几年，RSV（一种广泛传播的呼吸道疾病病原体）的治疗前景发生了显著变化。然而，大多数创新集中在针对老年人的预防疗法上，因为RSV感染可能对老年人致命。目前已有三种疫苗可用。

GSK

葛兰素史克

,

，

Pfizer

辉瑞

and

和

Moderna

莫德纳

.

。

But RSV is also the

但是RSV也是

leading

领先

cause of

原因

hospitalizations

住院治疗

among infants in the U.S., and in that age group, the need for new treatments remains significant.

在美国的婴儿中，而且在那个年龄组中，对新疗法的需求仍然很大。

There are no RSV vaccines available for young children. Last year

目前还没有适合幼儿的RSV疫苗。去年

the FDA paused multiple trials of RSV

FDA暂停了多项RSV试验

shots

镜头

following cases of severe RSV in a study run by Moderna. One vaccine, Pfizer’s Abrysvo, is available for pregnant women and can pass RSV protection over to newborns.

在莫德纳开展的一项研究中，有以下几例严重RSV病例。一种疫苗——辉瑞的阿布瑞索（Abrysvo）可供孕妇使用，并能将RSV保护传递给新生儿。

As a result, parents of young children largely rely on antibody drugs that can provide short-term protection against illness. One, approved more than two decades ago and named Synagis is limited to high-risk infants. The other, Sanofi’s and AstraZeneca’s Beyfortus, was

因此，幼儿的父母在很大程度上依赖能够提供短期疾病防护的抗体药物。一种是二十多年前获批、名为Synagis的药物，仅限高危婴儿使用；另一种是赛诺菲和阿斯利康的Beyfortus。

cleared in 2023

2023年清除

and has quickly become a blockbuster drug. Early demand was so strong for Beyfortus that Sanofi initially struggled with supply before

并且迅速成为了一种重磅药物。对Beyfortus的早期需求如此强劲，以至于赛诺菲最初在供应方面遇到了困难。

boosting its manufacturing capabilities

提升其制造能力

.

。

On Monday, Sanofi announced plans to

周一，赛诺菲宣布计划

accelerate shipping

加速运输

of Beyfortus to “ensure broad availability” ahead of the coming RSV season.

为确保即将到来的RSV季节“广泛可用”而提前准备Beyfortus。

Merck aims to show that Enflonsia, formerly known as clesrovimab,

默克公司旨在证明恩氟沙尼亚（Enflonsia），之前被称为克勒索维单抗（clesrovimab），

can grab some of Beyfortus’ market share. In testing, the drug

可以抢占Beyfortus的部分市场份额。在测试中，该药物

reduced

减少

the incidence by RSV

RSV的发病率

disease

疾病

compared to a placebo by 60%, and hospitalizations from illness by 84%, over the course of five months. Those results were enough to garner an approval, though Wall Street analysts have been skeptical as to whether they’re meaningfully different than the data supporting Beyfortus, leading to questions about Enflonsia’s sales potential..

与安慰剂相比，五个月内疾病住院率降低了60%，疾病导致的住院率降低了84%。这些结果足以获得批准，尽管华尔街分析师对这些数据是否与支持Beyfortus的数据有显著差异表示怀疑，这也引发了对Enflonsia销售潜力的质疑。

Merck’s drug may be more accessible than Beyfortus, however. Unlike Beyfortus, it can be given regardless of an infant’s weight. The drug can also be used as a single shot instead of two injections.

然而，默克公司的药物可能比Beyfortus更容易获得。与Beyfortus不同，无论婴儿的体重如何都可以使用。该药物还可以作为单次注射而不是两次注射使用。

“Enflonsia combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention to help protect infants from RSV,' said Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude Children’s Research Hospital and a study investigator, in a statement provided by Merck..

“Enflonsia结合了剂量便利性和有力的临床数据，显示RSV疾病发病率和住院率显著降低，这使其成为一种很有前景的新干预措施，有助于保护婴儿免受RSV的侵害，”圣裘德儿童研究医院传染病科主任、该研究的调查员奥克塔维奥·拉米洛在默克公司提供的一份声明中表示。

A panel advising the Centers for Disease Control and Prevention will meet later this month to discuss recommendations for using Enflonsia. Merck said drug shipments should be available before the start of the 2025-2026 RSV season.

疾控中心的一个咨询小组将在本月底开会讨论使用Enflonsia的建议。默克公司表示，药物运输应在2025-2026年RSV季节开始前到位。

The drug shouldn't be given to infants with a history of serious hypersensitivity reactions, such as anaphylaxis, to any of its components, Merck said.

默克公司表示，有过敏反应史的婴儿不应该给予这种药物，如对其任何成分有严重的过敏反应（如过敏性休克）。