The Food and Drug Administration on Wednesday approved an antibody drug that developer Johnson & Johnson expects will eventually become one of its top-selling medicines.

美国食品和药物管理局周三批准了一种抗体药物，该药物的开发商强生公司预计其最终将成为公司最畅销的药物之一。

The drug, which J&J will sell as Imaavy, was

该药物将由J&J公司以Imaavy名称销售，

cleared by the FDA

获得FDA批准

to treat adults and children 12 years of age or older who have an autoimmune condition known as generalized myasthenia gravis. The disease interferes with communication between nerves and muscles, leading to a diverse range of symptoms that can include fatigue, muscle weakness, difficulty breathing and changes in vision..

用于治疗12岁及以上患有全身性重症肌无力的成人和儿童，这是一种自身免疫性疾病。该疾病会干扰神经与肌肉之间的通信，导致多种症状，包括疲劳、肌肉无力、呼吸困难和视力变化。

Imaavy

伊玛维

is designed to lessen that interference by reducing levels of an immune system protein that mistakenly targets certain muscle receptors. In testing, treatment improved daily function versus placebo on a scale that assesses essential activities like talking, chewing and standing from a chair. Imaavy was also associated with an improvement in muscle weakness. .

旨在通过降低免疫系统蛋白水平来减少这种干扰，这种蛋白错误地针对某些肌肉受体。在测试中，治疗在评估基本活动（如说话、咀嚼和从椅子上站起来）的量表上，相比安慰剂改善了日常功能。Imaavy 还与肌肉无力的改善有关。

J&J estimates some 100,000 people in the U.S. have generalized myasthenia gravis, for whom Imaavy will be another option alongside recently approved medicines from

强生估计，美国约有10万名全身性重症肌无力患者，对于这些患者而言，Imaavy将是近期获批药物之外的另一个选择。

Argenx

Argenx

and

和

UCB

UCB

that work in a similar fashion. (Other, older drugs that work differently are also available.)

以类似方式起作用的药物。（也有其他作用不同的老药可用。）

J&J set Imaavy’s price to $12,480 per 1200 milligram vial, which it said is 'competitively priced' with other, similar drugs. The company added that, through a support program it’s established, commercially insured patients may not pay anything out of pocket.

强生将Imaavy的价格定为每1200毫克瓶12,480美元，称其价格“与其他类似药物相比具有竞争力”。该公司补充道，通过其设立的援助计划，商业保险患者可能无需自付任何费用。

The drug’s approval is significant for J&J, which

该药物的批准对J&J来说意义重大，

paid $6.5 billion

支付了65亿美元

to acquire its original developer, Momenta Pharmaceuticals, in 2020. Since then, it’s become central to J&J’s plans to build a new wave of immune medicines that can supplant the sales of aging blockbusters like Stelara and Simponi. The company

在2020年收购了其原始开发商Momenta Pharmaceuticals。从那时起，它已成为强生计划打造新一代免疫药物的核心，以取代Stelara和Simponi等老化的重磅药物的销售。公司

forecasts

预测

sales of Imaavy could eventually eclipse $5 billion a year at their peak.

Imaavy的销售额在其巅峰时期最终可能达到每年50亿美元。

Those lofty forecasts are based on J&J’s expectations that Imaavy could work in a wide array of diseases driven by “autoantibodies,” which are immune system proteins erroneously aimed at targets on the body’s own cells, rather than on pathogens.

这些崇高的预测基于强生的期望，即Imaavy可能在由“自身抗体”驱动的广泛疾病中发挥作用，这些“自身抗体”是免疫系统蛋白质，错误地针对身体自身细胞上的目标，而非病原体。

In the case of generalized myasthenia gravis, autoantibodies attach to either acetylcholine receptors or muscle-specific tyrosine kinases found on muscle cells. As a result, signals delivered via a neurotransmitter called acetylcholine can’t readily pass from nerves to muscles, leading to the disease’s symptoms. .

在全身性重症肌无力的情况下，自身抗体附着在肌肉细胞上的乙酰胆碱受体或肌肉特异性酪氨酸激酶上。结果，通过一种叫做乙酰胆碱的神经递质传递的信号无法顺利从神经传递到肌肉，导致了该疾病的症状。

Imaavy reduces levels of these autoantibodies by binding to a protein known for short as FcRn. This stops cells from helping antibodies, including harmful ones, persist in the blood, resulting in their breakdown. Its approval is limited to people who are positive for either acetylcholine receptors or muscle-specific tyrosine kinases. .

Imaavy通过与一种简称FcRn的蛋白质结合来降低这些自身抗体的水平。这会阻止细胞帮助抗体（包括有害抗体）在血液中持续存在，从而导致它们的分解。它的使用批准仅限于乙酰胆碱受体或肌肉特异性酪氨酸激酶呈阳性的人群。

J&J sees the drug’s mechanism as potentially helpful in rare diseases directly caused by autoantibodies, like myasthenia gravis, as well as autoantibody-mediated rheumatic conditions and pregnancy-related diseases that involve alloantibodies.

强生认为，该药物的机制可能对由自身抗体直接引起的罕见疾病（如重症肌无力）、自身抗体介导的风湿病以及涉及同种抗体的妊娠相关疾病有帮助。

'Today's FDA approval of Imaavy marks a historic milestone for the more than 240 million patients suffering with autoantibody diseases, many with few or no approved targeted treatments,' said David Lee, J&J’s global immunology therapeutic area head, in

“今天FDA批准Imaavy标志着超过2.4亿患有自身抗体疾病的患者迎来了一个历史性的里程碑，其中许多患者目前几乎没有或根本没有获批的靶向治疗，”强生全球免疫治疗领域主管David Lee表示。

the company’s statement

公司的声明

.

。