Eli Lilly has won a green light from the FDA for new dosing for its Alzheimer's disease therapy Kisunla, which carries a reduced risk of adverse reactions that may have held back its uptake in the market.

礼来公司已获得美国食品药品监督管理局（FDA）对其阿尔茨海默病治疗药物Kisunla新剂量的批准，该剂量降低了可能阻碍其市场接受的不良反应风险。

The US regulator has approved a label update with a new dosing schedule for

美国监管机构已批准更新标签，采用新的剂量计划。

Kisunla

基苏拉

(donanemab) that, in clinical trials, significantly lowered the chances that patients treated with the antibody would develop a brain swelling side effect known as ARIA-E (amyloid-related imaging abnormalities with oedema/effusion).

（donanemab）在临床试验中显著降低了接受该抗体治疗的患者出现一种称为ARIA-E（淀粉样蛋白相关影像学异常伴水肿/渗出）的脑肿胀副作用的可能性。

ARIA-E is recognised as a potentially life-threatening complication of amyloid-targeting therapies like Kisunla and Eisai/Biogen's rival

ARIA-E 被认为是像 Kisunla 以及 Eisai/Biogen 的竞争产品这类针对淀粉样蛋白的疗法潜在的危及生命的并发症。

Leqembi

勒克姆比

(lecanemab), and the risk – along with fairly modest efficacy – has been held up as one reason why the two drugs have failed to gather much sales momentum since they were approved.

（lecanemab），以及风险——加上相对较低的疗效——被认为是这两种药物自获批以来未能获得太多销售动力的原因之一。

Lilly tested a small modification to the dosing schedule for Kisunla in the TRAILBLAZER-ALZ 6, which showed that simply deferring one dose in the titration phase of treatment reduced ARIA-E at both 24 weeks and 52 weeks, without affecting its ability to clear amyloid deposits in the brain or reduce levels of the P-tau217 biomarker..

莉莉在TRAILBLAZER-ALZ 6试验中对Kisunla的剂量计划进行了小修改，结果显示，仅在治疗的滴定阶段推迟一剂就能减少24周和52周时的ARIA-E发生率，同时不会影响其清除大脑中的淀粉样蛋白沉积或降低P-tau217生物标志物水平的能力。

The primary readout at 24 weeks showed the incidence of the side effect was 14% in patients receiving the modified titration compared with 24% for those receiving the original regimen, a 41% reduction in risk, which trial investigator Elly Lee of the Irvine Center for Clinical Research said was a 'meaningful advancement.'.

24周时的主要结果显示，接受改良滴定的患者副作用发生率为14%，而接受原始方案的患者为24%，风险降低了41%。尔湾临床研究中心的试验研究员Elly Lee表示，这是一个“有意义的进步”。

After a year, the rates were 16% and 25%, respectively, which was a 35% reduction. There was, however, no significant difference between the groups in ARIA-H, bleeds in the brain, which is the other major form of ARIA side effect.

一年后，发生率分别为16%和25%，降低了35%。 然而，两组之间在ARIA-H、即脑出血这种另一种主要形式的ARIA副作用方面没有显著差异。

'We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients,' said Brandy Matthews, Lilly's head of global and US medical affairs for Alzheimer's.

“我们相信，Kisunla的这一标签更新将大大帮助医疗专业人员评估患者的适当治疗方案，”礼来公司阿尔茨海默病全球及美国医学事务主管布兰迪·马修斯表示。

In its first-quarter update, Lilly said that sales of Kisunla came in at $21.5 million, $18.4 million of that from the US, while Leqembi generated $96 million globally in the same three-month period. That is a far cry from the expectations of blockbuster sales that accompanied both drugs as they went through clinical testing..

在第一季度的更新中，礼来公司表示，Kisunla的销售额为2150万美元，其中1840万美元来自美国，而Leqembi在同一三个月内的全球销售额为9600万美元。这与这两种药物在临床试验期间所伴随的重磅销售预期相去甚远。

One reason for the lacklustre growth is that the benefits (estimated as a four- to six-month delay in cognitive decline) are outweighed by the risk of side effects and the need for careful monitoring of patients to guard against them, as well as regular clinic visits for infusions that add to the cost of providing the medicines..

增长乏力的一个原因是，益处（估计可将认知能力下降推迟四到六个月）被副作用的风险、为防范副作用而对患者进行密切监测的必要性，以及增加药物提供成本的定期诊所输液所抵消。