U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV. RSV sends tens of thousands of American children to the hospital each year. The virus is a cold-like disease for most healthy people. But it can be life-threatening in the very young and very old. Last year, a large increase in RSV cases crowded U.S. hospitals with sick children. The Food and Drug Administration (FDA) approved the injection for infants and children up...
U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV. RSV sends tens of thousands of American children to the hospital each year. The virus is a cold-like disease for most healthy people. But it can be life-threatening in the very young and very old. Last year, a large increase in RSV cases crowded U.S. hospitals with sick children. The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.
美国官员周一批准了第一种长效药物，用于保护婴儿和幼儿免受呼吸道合胞病毒（RSV）的侵害。RSV 每年将数万名美国儿童送往医院。 对于大多数健康人来说，该病毒是一种类似感冒的疾病。 但对于年幼和年老的人来说，它可能会危及生命。 去年，呼吸道合胞病毒病例大幅增加，美国医院里挤满了患病儿童。美国食品和药物管理局 (FDA) 批准该注射剂用于面临严重 RSV 风险增加的 2 岁以下婴儿和儿童。
The approval helps “reduce the impact of RSV disease on children, families and the health care system” said FDA's Dr. John Farley in a statement. The drugmaker AstraZeneca developed the drug. It will be sold under the name Beyfortus. It is a laboratory-made version of an antibody that helps the immune system fight off RSV. Under the FDA approval, babies — including small infants — can receive a single injection to protect against their first season of RSV, which usually lasts about five months. Children up to age 2 can receive another dose to protect them during their second season facing the virus.
FDA 的 John Farley 博士在一份声明中表示，该批准有助于“减少 RSV 疾病对儿童、家庭和医疗保健系统的影响”。制药商阿斯利康开发了这种药物。 它将以 Beyfortus 的名称出售。 它是实验室制造的抗体，可以帮助免疫系统抵抗 RSV。根据 FDA 的批准，婴儿（包括小婴儿）可以接受单次注射，以预防 RSV 的第一个季节，该季节通常持续约五个月。 2 岁以下的儿童可以接受另一剂疫苗，以在面临病毒的第二个季节提供保护。
Beyfortus is already approved in Canada, Europe and Britain. It did not immediately announce the U.S. price of the treatment. FDA officials approved the drug based on three studies. They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent among infants and children 2 and younger. Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug. A similar antibody drug won FDA approval more than 20 years ago. But the drug is only recommended for high-risk babies and requires monthly injections. Doctors say that drug is underused. But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.
Beyfortus 已在加拿大、欧洲和英国获得批准。 它没有立即公布该疗法在美国的价格。FDA 官员根据三项研究批准了该药物。 他们表明 Beyfortus 可以将婴儿和 2 岁及以下儿童感染 RSV 的风险降低 70% 至 75%。疾病控制和预防中心的顾问将于下月初开会，准确推荐谁应该服用该药物。类似的抗体药物在 20 多年前就获得了 FDA 的批准。 但该药仅推荐用于高危婴儿，并且需要每月注射一次。 医生说这种药物没有得到充分利用。 但他们预计阿斯利康注射剂的持久效果会更受欢迎。
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die. After years of setbacks for RSV research, drugmakers have made big improvements this year. In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In August, the FDA is expected to make a decision on approving Pfizer’s vaccine for pregnant women. The aim is for the vaccine to pass along protection to their newborns.
在美国，每年约有 58,000 名 5 岁以下儿童因 RSV 住院。 数百人死亡。RSV 研究经历了多年的挫折后，制药商今年取得了重大进展。 今年 5 月，FDA 批准了葛兰素史克和辉瑞公司的两种针对老年人的 RSV 疫苗。8月份，FDA预计将做出批准辉瑞孕妇疫苗的决定。 疫苗的目的是为新生儿提供保护。
View more
