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首个获准用于新生儿和小婴儿的疟疾药物

First Malaria Drug Approved for Newborns and Small Babies

Drugs 等信源发布 2025-07-10 00:38

可切换为仅中文


WEDNESDAY, July 9, 2025 — A new malaria treatment has been approved for newborns and infants under 11 pounds, filling a major gap in care for some of the most vulnerable children.

2025年7月9日,星期三——一种新的疟疾治疗方法已获批用于体重低于11磅的新生儿和婴儿,填补了针对最脆弱儿童群体护理中的一个重大空白。

The medicine, called Coartem Baby (also known as Riamet Baby), was approved by Switzerland’s health agency,

这种药物名为Coartem Baby(也称Riamet Baby),已获得瑞士卫生机构的批准,

Swissmedic

瑞士医药管理局

,

The Washington Post

华盛顿邮报

reported.

已报告。

It was developed by the Geneva-based nonprofit

它是由总部位于日内瓦的非营利组织开发的

Medicines for Malaria Venture

抗疟疾风险投资药品组织

and the Swiss drug company

和瑞士制药公司

Novartis

诺华

.

“The newly authorized product addresses a critical treatment gap for one of the most vulnerable patient populations — young infants suffering from malaria,” Swissmedic said in a

瑞士医药管理局表示:“这种新批准的产品填补了最脆弱患者群体——患疟疾的幼婴——的关键治疗空白。”

statement

声明

.

Malaria is caused by a parasite spread through

疟疾是由寄生虫传播引起的

mosquito

蚊子

bites. It’s preventable and treatable, but sickened 263 million people worldwide in 2023 and claimed nearly 600,000 lives, according to World Health Organization (WHO)

咬伤。据世界卫生组织(WHO)称,这种疾病是可以预防和治疗的,但2023年在全球范围内感染了2.63亿人,并夺走了近60万人的生命。

data

数据

.

Children under 5 are especially at risk. In Africa alone, they made up 76% of malaria deaths, the WHO

五岁以下的儿童尤其面临风险。仅在非洲,他们就占了疟疾死亡人数的76%,世界卫生组织表示。

reports

报告

.

Bhargavi Rao

巴嘎瓦蒂·劳

, co-director of the Malaria Center at the London School of Hygiene and Tropical Medicine, said the new drug will be especially helpful for very small and malnourished babies, who often don’t qualify for standard treatments.

伦敦卫生与热带医学学院疟疾中心主任联合主任表示,这种新药将对非常幼小和营养不良的婴儿特别有帮助,这些婴儿通常不符合标准治疗的条件。

“Traditionally, people had said sort of small babies didn’t get malaria because they were protected by maternal immunity, but I think we’re increasingly recognizing that burden in very small children is not insubstantial and they just present in very different ways. Even very low levels of parasites can give fairly significant severe malaria and death,” Rao told .

“传统上,人们认为小婴儿不会得疟疾,因为他们受到母体免疫力的保护,但我认为我们越来越认识到,非常年幼的儿童的疾病负担并不轻,而且他们的表现方式非常不同。即使是非常低水平的寄生虫也可能导致相当严重的疟疾和死亡,”拉奥说道。

The Post.

邮报。

“This is a drug that can be mixed with breast milk, which is brilliant and much easier to deliver,” she said.

“这种药物可以与母乳混合,非常棒,也更容易喂食,”她说道。

Coartem Baby contains two medicines —

Coartem Baby含有两种药物——

artemether and lumefantrine

青蒿琥酯和卢米泛汀

— that work together to fight the malaria parasite. These drugs were already approved for use in patients weighing over 11 pounds.

——这些药物共同作用,对抗疟疾寄生虫。它们已经被批准用于体重超过11磅的患者。

The new version:

新版本:

Is approved for infants weighing 4.4 to 11 pounds.

适用于体重4.4至11磅的婴儿。

Dissolves easily, including in breast milk.

易溶解,包括在母乳中。

Has a sweet cherry flavor to make it easier to give to infants.

具有甜樱桃味,更容易喂给婴儿。

The treatment was approved under Swissmedic’s Marketing Authorization for Global Health Products (MAGHP), which helps speed access to medicines for diseases affecting sub-Saharan Africa,

该治疗方案根据瑞士药监局的全球健康产品营销授权(MAGHP)获得批准,这有助于加快撒哈拉以南非洲地区疾病药物的获取速度。

The Post

邮报

said.

说。

So far, eight African countries have signed on to review and approve the treatment. They are Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Uganda and Tanzania. Once submitted for review, these countries are expected to authorize the drug within 90 days.

迄今为止,已有八个非洲国家签署协议,审查并批准该疗法。它们是布基纳法索、科特迪瓦、肯尼亚、马拉维、莫桑比克、尼日利亚、乌干达和坦桑尼亚。一旦提交审查,这些国家预计将在90天内授权该药物。

Malaria vaccines are also now available in many countries. Children can start getting vaccinated around 5 months of age, according to WHO. By April of this year, vaccines were being rolled out in 19 countries due to what WHO called 'unprecedented' demand.

许多国家也已经有了疟疾疫苗。根据世界卫生组织的说法,儿童大约在五个月大的时候就可以开始接种疫苗。截至今年四月,由于世卫组织所称的“前所未有的”需求,疫苗已在19个国家推出。

Still, medicines are needed to treat babies too young for the vaccine or those who become infected anyway.

仍然需要药物来治疗太小而不能接种疫苗的婴儿或那些仍然受到感染的人。

Novartis said it plans to offer the new treatment on what is essentially a nonprofit basis in places where malaria is common.

诺华表示,它计划在疟疾常见的地方基本上以非营利的方式提供这种新疗法。

“[We’re] proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve,' Novartis CEO

“我们为开发出首个适用于新生儿和幼婴的临床验证疟疾治疗方案感到自豪,确保最小和最脆弱的群体最终能够得到他们应得的护理。”诺华首席执行官表示。

Dr. Vas Narasimhan

瓦斯·纳拉希汉博士

said.

说。

In all, 95% of all malaria deaths happen in WHO’s Africa region, the organization said. Many families lack access to basic tools like mosquito nets or medicines,

世卫组织表示,总体而言,95%的疟疾死亡病例发生在世卫组织非洲区域。许多家庭无法获得蚊帐或药物等基本工具,

The Post

邮报

said.

说。

Experts say climate change is making the situation worse. Longer mosquito seasons and rising temperatures could put more than 5 billion people at risk for malaria by 2040, including 1 billion in Africa alone.

专家表示,气候变化使情况更加严重。更长的蚊虫季节和不断上升的气温可能会让超过50亿人到2040年面临感染疟疾的风险,其中仅非洲就有10亿人。

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