来金珠单抗(Lebrikizumab) - 药物靶点：IL-13_在研适应症：特应性皮炎，慢性鼻窦炎伴鼻息肉，鼻息肉_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

ANTI-IL-13、Lebrikizumab (genetical recombination) (JAN)、Lebrikizumab (USAN/INN)

+ [12]

靶点

IL-13

作用机制

IL-13抑制剂(白细胞介素-13抑制剂)

治疗领域

免疫系统疾病遗传病与畸形皮肤和肌肉骨骼疾病+ [3]

在研适应症

特应性皮炎慢性鼻窦炎伴鼻息肉鼻息肉+ [2]

非在研适应症

气道病变气道阻塞过敏性哮喘+ [5]

原研机构

Genentech, Inc.

在研机构

Eli Lilly & Co.

Almirall SAEli Lilly Japan KK

+ [1]

非在研机构

Hoffmann-La Roche, Inc.

Genentech, Inc.Tanox, Inc.

+ [2]

最高研发阶段批准上市

首次获批日期

欧盟 (2023-11-16),

特应性皮炎

最高研发阶段(中国)临床3期

特殊审评快速通道 (美国)

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序列信息

Sequence Code 142719L

来源: *****

Sequence Code 9082543H

来源: *****

关联

62

项与来金珠单抗相关的临床试验

NCT06444165 / Completed临床3期

Study to Assess Lebrikizumab Pen Ease of Use in Patients With Atopic Dermatitis

The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection.
This study involves one study visit.

开始日期2024-06-04

申办/合作机构

Eli Lilly & Co.

NCT06338995 / Recruiting临床3期

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Efficacy and Safety Study of Lebrikizumab/ LY3650150 in Adults With Chronic Rhinosinusitis With Nasal Polyps on a Background Therapy With Intranasal Corticosteroids

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

开始日期2024-04-29

申办/合作机构

Eli Lilly & Co.

NCT06339008 / Recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants With Perennial Allergic Rhinitis

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months

开始日期2024-04-26

申办/合作机构

Eli Lilly & Co.

100 项与来金珠单抗相关的临床结果

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100 项与来金珠单抗相关的转化医学

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100 项与来金珠单抗相关的专利（医药）

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121

项与来金珠单抗相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-01-23·The British journal of dermatology

Lebrikizumab improved itch and reduced the extent of itch interference on sleep in patients with moderate-to-severe atopic dermatitis: two randomized, placebo-controlled, phase III trials

Article

作者: Elmaraghy, Hany ; Legat, Franz J ; Serra-Baldrich, Esther ; Liu, Zhuqing ; Pierce, Evangeline ; Sun, Luna ; Yosipovitch, Gil ; Rosmarin, David ; Lio, Peter A ; Ständer, Sonja ; Casillas, Marta

Itch and sleep loss due to itch are prevalent symptoms of moderate-to-severe atopic dermatitis, significantly impairing patients’ quality of life and wellbeing. First-line topical therapy is insufficient for most patients and there is an unmet need for effective treatments that provide symptom relief and quality of life improvement. In two randomized, placebo-controlled, phase III trials, significantly more patients treated with the novel monoclonal antibody lebrikizumab had ≥ 3-point improvement in Pruritus Numeric Rating Scale by week 16 vs. patients treated with placebo. In addition, significantly more patients treated with lebrikizumab achieved ≥ 1-point improvement in Sleep-Loss Scale score by week 16 vs. placebo. Onset of itch relief was rapid, occurring within the first few days of treatment.

2024-01-01·Dermatology and therapy

Correction to: Matching-Adjusted Indirect Comparison of the Long-Term Efficacy Maintenance and Adverse Event Rates of Lebrikizumab versus Dupilumab in Moderate-to-Severe Atopic Dermatitis

作者: Akmaz, Bülent ; Rand, Kim ; Ramos-Goñi, Juan Manuel ; Solé-Feu, Laia ; Armario-Hita, José-Carlos

155

项与来金珠单抗相关的新闻（医药）

2024-07-22

·Pharmaceutical Technology

Ilumetri and Ebglyss spur Almirall’s growth in dermatology

Almirall expects EBITDA of between €175m and €190m this year. Image credit: Shutterstock/ T. Schneider. Almirall has reported a 6.7% increase in total net sales for the first half of 2024, with the company’s European dermatology business spurring much of the company’s revenue streams. Almirall generated a total of €497.2m ($541.4m) in H1 this year, a year-over-year (YOY) sales increase of 3.2%. The results meant the Spanish pharma reiterated its growth guidance for 2024, estimating an EBITDA of between €175m and €190m, as per a 22 July press release. Shares in the company opened 3.9% higher based on the financial results. Almirall has a €2bn market cap. Almirall’s dermatology business in Europe was the engine for much of the company’s growth, propped up by higher sales of the psoriasis treatment Ilumetri (tildrakizumab) and the recent launch of Ebglyss (lebrikizumab) for atopic dermatitis. In an earnings call on 22 July, Almirall CEO Carlos Gallardo said: “It’s still early days, but we are very encouraged by the strong progress of the product sales [for Ebgylss].” See Also: Rusan Pharma’s API Plant in Ankleshwar Receives USFDA GMP Approval UK MHRA approves Lupin and Zentiva’s raltegravir for HIV Gallardo added that the company expects to “capture a significant share of the advanced therapies market in atopic dermatitis”. Ilumetri, an anti-interleukin-23 (IL-23) antibody, is Almirall’s best-selling product. The drug reached over €100m in sales in H1 this year, representing a 25% increase compared to the same period in 2023. Almirall said it forecasts €250m in peak sales for the drug in 2024. Ilumetri is the European brand name for Ilumya – Almirall having licensed European rights for the drug from Sun Pharma in 2016. European sales for the drug are estimated to reach $300m by 2030, whilst US sales are expected to soar past $1.2bn by the same year, according to analysis by GlobalData. GlobalData is the parent company of Pharmaceutical Technology. Ebgylss meanwhile was recently launched in Germany, the UK, and Norway, and was recommended by England’s National Institute for Health and Care Excellence ( Nice ) for use on the NHS last month. Further rollouts in Denmark, Spain, and Austria are expected later this year for the drug. Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Globally, Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. Unlike its European counterpart, Almirall’s US dermatology business sales decreased by 4.1%, though CFO Mike McClellan said the business is showing “nearly stable results”, but it is under pressure from “ongoing generic erosion” in the country.

上市批准并购生物类似药财报

2024-07-11

·PMLiVE

Almirall announces NICE recommendation for Ebglyss in atopic dermatitis

Almirall has announced that the National Institute for Health and Care Excellence (NICE) has recommended Ebglyss (lebrikizumab) to treat atopic dermatitis (AD) patients on the NHS in England and Wales. The IL-13 inhibitor can now be used to treat moderate-to-severe AD in adults and adolescents aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy. NICE’s decision follows the Medicines and Healthcare products Regulatory Agency’s approval of the therapy in December. Typically referred to as eczema, AD is an inflammatory disease that causes the skin to become itchy, dry and cracked. The incidence of AD appears to have increased in recent decades, with approximately 5.2 million adults and 2.5 million children in the UK affected by moderate or severe cases of the condition. Ebglyss, which also received approval from the European Commission last year, represents “a step forward” for uncontrolled moderate-to-severe AD patients, Almirall said, citing the therapy’s selective mechanism of action, efficacy, safety profile and four-weekly maintenance dosing. The regulatory approvals were supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescents with moderate-to-severe AD, as well as data from the phase 3 ADhere study assessing the drug in combination with topical corticosteroids. At week 16, almost 60% of patients experienced at least a 75% reduction in disease severity when receiving Ebglyss monotherapy in the ADvocate studies and nearly 70% of patients receiving Ebglyss combined with standard-of-care topical corticosteroids achieved the 75% reduction in the ADhere trial. Results from the clinical development programme also showed that 80% of patients who responded to Ebglyss treatment at week 16 maintained skin clearance and itch relief for up to two years with monthly maintenance dosing. Jorgen Damsbo, general manager at Almirall UK, described NICE’s recommendation as a “testament to the benefits [the] treatment can bring to patients”. Almirall has licenced the rights to develop and commercialise Ebglyss for use as a treatment for dermatology indications in Europe, while Eli Lilly has exclusive rights for the development and commercialisation of the drug in the US and the rest of the world.

临床结果临床3期上市批准

2024-07-10

·Firstwordpharma

Almirall’s Ebglyss gains NICE recommendation for atopic dermatitis

Almirall announced Wednesday that the UK's National Institute for Health and Care Excellence (NICE) recommended Ebglyss (lebrikizumab) as a treatment option for moderate-to-severe atopic dermatitis in adolescents and adults who have previously failed on at least one systemic immunosuppressant, or when these treatments are deemed unsuitable.The company noted that the IL-13-directed monoclonal antibody can now be prescribed routinely to eligible patients aged 12 and above weighing at least 40 kg through the NHS in England and Wales, in line with a commercial agreement which entails a simple discount patient access scheme for the drug.Ebglyss was cleared to treat atopic dermatitis in the EU and UK last year, based on favourable findings from three Phase III studies: ADvocate 1 and ADvocate 2 evaluating the drug as monotherapy, and ADhere investigating its combination with topical corticosteroids. Results demonstrated early efficacy of Ebglyss at week 16, achieving a 75% reduction in disease extent and severity (EASI-75) in nearly six out of 10 patients.“The NICE recommendation for lebrikizumab..is testament to the benefits this treatment can bring to patients due to its demonstrated efficacy, with 4-weekly maintenance dosing and an acceptable safety profile,” said Jorgen Damsbo, general manager at Almirall UK. Key opinion leaders interviewed by FirstWord last year said Ebglyss is at least as efficacious as Sanofi and Regeneron's Dupixent (dupilumab), with its monthly dosing being a significant advantage.The Spanish drugmaker holds European rights to Ebglyss from Eli Lilly, which acquired the asset through its $1.1-billion takeout of Dermira in 2020. The FDA, however, turned down Lilly’s marketing application for the drug in October last year, citing third-party manufacturing issues.rd-party manufacturing issues.

临床3期临床结果上市批准并购生物类似药

100 项与来金珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09633	来金珠单抗	-	DB11914

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
特应性皮炎	欧盟	Almirall SA	2023-11-16
特应性皮炎	冰岛	Almirall SA	2023-11-16
特应性皮炎	列支敦士登	Almirall SA	2023-11-16
特应性皮炎	挪威	Almirall SA	2023-11-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性鼻窦炎伴鼻息肉	临床3期	美国	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	比利时	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	保加利亚	Eli Lilly & Co.	2024-04-29
慢性鼻窦炎伴鼻息肉	临床3期	意大利	Eli Lilly & Co.	2024-04-29
鼻息肉	临床3期	美国	Eli Lilly & Co.	2024-04-29
鼻息肉	临床3期	比利时	Eli Lilly & Co.	2024-04-29
鼻息肉	临床3期	保加利亚	Eli Lilly & Co.	2024-04-29
鼻息肉	临床3期	意大利	Eli Lilly & Co.	2024-04-29
常年性变应性鼻炎	临床3期	美国	Eli Lilly & Co.	2024-04-26
阿尔茨海默症	临床3期	中国	罗氏（中国）投资有限公司	2021-11-30

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05372419 (ADmirable, PRNewswire) 人工标引	临床3期	特应性皮炎一线	50	Lebrikizumab	鏇簾壓構夢鹹齋鬱製憲(淵鏇遞鑰鏇獵鬱獵鏇夢) = 廠製遞製獵鏇積夢鑰選醖繭願構艱襯齋遞鹹願 (願繭範觸積艱積憲鑰醖 ) 更多	积极	2024-03-11
NEWS 人工标引	临床3期	特应性皮炎一线	-	Lebrikizumab	壓鑰鑰範膚範鹹壓積廠(蓋夢遞築醖築積襯襯構) = 鏇襯築範齋遞廠窪糧遞淵糧選構鑰鏇襯顧壓壓 (獵蓋構夢鏇淵襯鏇積夢 )	积极	2023-10-24
NCT04392154 (ADjoin, Corporate Publications) 人工标引	临床3期	特应性皮炎	-	Lebrikizumab 250 mg Monthly (Q4W) (ADvocate 1&2 → ADjoin)	衊憲遞鹹憲範蓋鹽襯鬱(獵範餘築構淵簾簾鹽鹹) = Less than three percent of patients experienced AEs leading to treatment discontinuation 壓憲糧鹽積窪鏇廠淵淵 (網築窪簾醖壓獵窪鑰獵 )	积极	2023-10-20
				Lebrikizumab 250 mg Every two weeks (Q2W) (ADvocate 1&2 → ADjoin)
ADopt-VA (EADV2023)	临床3期	特应性皮炎	-	Lebrikizumab	鹽觸糧蓋醖鹽鬱衊製顧(構顧鏇範範願觸製鹹蓋) = 窪淵醖窪簾醖鏇醖醖醖範醖齋鏇壓鑰襯鑰網鹽 (膚齋鏇壓鏇壓構築簾製 ) 更多	积极	2023-10-11
				Placebo	鹽觸糧蓋醖鹽鬱衊製顧(構顧鏇範範願觸製鹹蓋) = 鹽襯壓窪網鏇齋衊積鹽範醖齋鏇壓鑰襯鑰網鹽 (膚齋鏇壓鏇壓構築簾製 ) 更多
Phase 3 (EADV2023)	临床3期	特应性皮炎	-	Lebrikizumab	範觸窪願獵願鬱鹽製衊(鹹醖淵夢築淵鹹製膚廠) = 網壓蓋壓壓鏇壓顧簾糧窪觸獵醖衊壓壓遞襯網 (醖遞顧憲積醖築壓鹽築 ) 更多	积极	2023-10-11
				Placebo	範觸窪願獵願鬱鹽製衊(鹹醖淵夢築淵鹹製膚廠) = 憲壓鑰製蓋構餘鏇艱顧窪觸獵醖衊壓壓遞襯網 (醖遞顧憲積醖築壓鹽築 ) 更多
ADvocate1&2, ADjoin (EADV2023)	临床3期	阿尔茨海默症	-	Lebrikizumab 250 mg every two weeks (LEB Q2W)	夢餘簾網衊繭窪夢鏇壓(餘糧夢選鏇醖築構鑰糧) = 積淵願獵夢廠艱蓋製衊網築壓範餘製積糧廠範 (淵齋鬱獵憲憲醖築築顧 )	-	2023-10-11
				Lebrikizumab every 4 weeks (LEB Q4W)	夢餘簾網衊繭窪夢鏇壓(餘糧夢選鏇醖築構鑰糧) = 積衊襯壓願願鏇窪夢遞網築壓範餘製積糧廠範 (淵齋鬱獵憲憲醖築築顧 )
NCT05149313 (ADvantage, EADV2023)	临床3期	湿疹 \| 特应性皮炎	331	Lebrikizumab + Topical Corticosteroids	鹹獵願鑰簾壓選觸鹹顧(壓糧範窪範鏇鹹夢繭窪) = 獵範蓋廠鹽構願選齋積築淵顧網鬱觸膚鹹憲衊 (顧選鏇蓋鏇繭窪夢繭憲 ) 更多	积极	2023-10-11
				Placebo + Topical Corticosteroids	鹹獵願鑰簾壓選觸鹹顧(壓糧範窪範鏇鹹夢繭窪) = 築鹽憲製獵憲繭構鏇觸築淵顧網鬱觸膚鹹憲衊 (顧選鏇蓋鏇繭窪夢繭憲 ) 更多
ADvocate1 and ADvocate2 (EADV2023)	临床3期	-	-	Lebrikizumab monotherapy	窪積顧鹽鹹繭構襯簾製(廠衊壓壓膚觸糧餘簾鑰) = 窪醖憲築餘餘鬱觸觸廠窪網壓餘鑰膚壓夢築網 (膚壓餘衊餘鏇廠艱觸醖 ) 更多	-	2023-10-11
				Placebo	窪積顧鹽鹹繭構襯簾製(廠衊壓壓膚觸糧餘簾鑰) = 觸獵鹽願鑰鏇製艱廠製窪網壓餘鑰膚壓夢築網 (膚壓餘衊餘鏇廠艱觸醖 ) 更多
ADvocate1, ADvocate2 (EADV2023)	临床3期	特应性皮炎	-	Lebrikizumab Q2W	範窪鑰齋夢齋膚艱顧壓(獵餘鏇蓋淵鏇觸遞鹽齋) = 範鑰構遞範窪積蓋廠鑰窪獵鹹繭鑰淵糧鑰衊獵 (鬱獵夢選簾鬱鏇鑰簾鏇 ) 更多	积极	2023-10-11
				Lebrikizumab Q4W	範窪鑰齋夢齋膚艱顧壓(獵餘鏇蓋淵鏇觸遞鹽齋) = 鏇遞選壓繭網獵蓋衊製窪獵鹹繭鑰淵糧鑰衊獵 (鬱獵夢選簾鬱鏇鑰簾鏇 ) 更多
ADvocate1 and ADvocate2 (EADV2023)	临床3期	-	851	Lebrikizumab 250 mg Q2W	衊範餘鹽獵憲遞鹽製鹹(鬱獵窪願遞獵選網壓糧) = 鏇構構顧網壓夢糧範選廠製醖淵淵選蓋獵鬱願 (餘選鏇艱築餘顧襯襯繭 ) 更多	-	2023-10-11