太阳制药的Ilumya扩展申请获美国FDA受理审查-动脉网

Sun Pharma’s Ilumya expansion bid gets USFDA nod for review

economictimes.indiatimes 等信源发布 2026-03-16 23:46

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Mumbai: India’s largest drugmaker Sun Pharmaceutical has received a nod from the US Food and Drug Administration (

孟买：印度最大的制药商太阳制药已获得美国食品药品监督管理局（FDA）的批准。

USFDA

美国食品药品监督管理局

) to expand the therapeutic use of its innovative drug

）以扩大其创新药物的治疗用途

Ilumya

伊利姆亚

for the treatment of adults with active

用于治疗活跃的成年人

psoriatic arthritis

银屑病关节炎

。

The US regulator has accepted Sun’s supplemental

美国监管机构已接受Sun的补充材料

Biologics

生物制品

License Application (sBLA) for review, the company said in a statement on Monday.

该公司在周一的一份声明中表示，已提交许可申请（sBLA）以供审查。

The regulatory acceptance marks a significant step for Sun in its ambition to strengthen its innovative medicines pipeline.

监管机构的批准标志着太阳制药在加强其创新药物管道方面迈出了重要一步。

The application seeks approval to use Ilumya (

该申请寻求批准使用Ilumya（

tildrakizumab

替拉珠单抗

) for the treatment of adults with active psoriatic arthritis, a

) 用于治疗患有活动性银屑病关节炎的成人，

chronic autoimmune condition

慢性自身免疫性疾病

that affects joints and is often associated with

影响关节，并且常与...相关联

psoriasis

银屑病

. The regulator has set a target action date of October 29.

监管机构已将10月29日定为目标行动日期。

If approved, Ilumya would expand beyond its current indication for moderate-to-severe plaque psoriasis to address a broader segment of patients suffering from psoriatic disease.

如果获得批准，Ilumya将超出其中重度斑块状银屑病的当前适应症范围，覆盖更广泛的银屑病患者群体。

Live Events

现场活动

Rick Ascroft, CEO of

里克·阿斯克罗夫特，首席执行官

Sun Pharma

太阳制药

North America, said: “For many people living with psoriatic disease, joint symptoms often add another layer of burden.” “As we continue to strengthen Sun Pharma’s innovative portfolio, we look forward to working with the FDA throughout the review process.”

北美地区表示：“对于许多患有银屑病的人来说，关节症状往往增加了另一层负担。” “随着我们不断加强太阳制药的创新产品组合，我们期待在整个审查过程中与 FDA 合作。”

According to estimates, roughly one in three patients with psoriasis eventually develops psoriatic arthritis.

据估计，大约三分之一的银屑病患者最终会发展为银屑病关节炎。

The submission to the regulator is supported by results from the INSPIRE-1 and INSPIRE-2 Phase 3

向监管机构提交的文件得到了INSPIRE-1和INSPIRE-2第三阶段试验结果的支持。

clinical trials

临床试验

, which evaluated the drug’s efficacy and safety in adults with active psoriatic arthritis over a 52-week period.

，该研究在为期 52 周的时间内评估了这种药物对活动性银屑病关节炎成人患者的疗效和安全性。

Globally, Ilumya has received marketing approvals from more than 55 health authorities, including in India, Japan, EU, China, Australia and Canada.

在全球范围内，Ilumya已获得包括印度、日本、欧盟、中国、澳大利亚和加拿大等55个卫生当局的上市批准。

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