Delving into the Latest Updates on Lebrikizumab with Synapse

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.

Start Date04 Jun 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06338995 / RecruitingPhase 3

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.

Start Date29 Apr 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06339008 / RecruitingPhase 3

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

Start Date26 Apr 2024

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Lebrikizumab

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100 Translational Medicine associated with Lebrikizumab

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100 Patents (Medical) associated with Lebrikizumab

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121

Literatures (Medical) associated with Lebrikizumab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Reichert, Janice M ; Crescioli, Silvia ; Kaplon, Hélène ; 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.

23 Jan 2024·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

Author: 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.

01 Jan 2024·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

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

83

News (Medical) associated with Lebrikizumab

22 Jul 2024

·www.pharmaceutical-technology.com

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.

Drug ApprovalAcquisitionBiosimilarFinancial Statement

11 Jul 2024

·pmlive.com

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.

Clinical ResultPhase 3Drug Approval

10 Jul 2024

·firstwordpharma.com

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.

Phase 3Clinical ResultDrug ApprovalAcquisitionBiosimilar

100 Deals associated with Lebrikizumab

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KEGG	Wiki	ATC	Drug Bank
D09633	Lebrikizumab	-	DB11914

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	EU	Almirall SA	16 Nov 2023
Dermatitis, Atopic	IS	Almirall SA	16 Nov 2023
Dermatitis, Atopic	LI	Almirall SA	16 Nov 2023
Dermatitis, Atopic	NO	Almirall SA	16 Nov 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis with nasal polyps	Phase 3	US	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	BE	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	BG	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	IT	Eli Lilly & Co.	29 Apr 2024
Nasal Polyps	Phase 3	US	Eli Lilly & Co.	29 Apr 2024
Nasal Polyps	Phase 3	BE	Eli Lilly & Co.	29 Apr 2024
Nasal Polyps	Phase 3	BG	Eli Lilly & Co.	29 Apr 2024
Nasal Polyps	Phase 3	IT	Eli Lilly & Co.	29 Apr 2024
Rhinitis, Allergic, Perennial	Phase 3	US	Eli Lilly & Co.	26 Apr 2024
Alzheimer Disease	Phase 3	CN	Roche China Holding Ltd.	30 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05372419 (ADmirable, PRNewswire) Manual	Phase 3	Dermatitis, Atopic First line	50	Lebrikizumab	xxnbgrptsq(iytxqfwcjg) = lobgnkvayk wxgwrsunux (rhazgepxhc ) View more	Positive	11 Mar 2024
NEWS Manual	Phase 3	Dermatitis, Atopic First line	-	Lebrikizumab	wkoprvnlzk(bxrnlybmzu) = upohbrgdyw qbzsamllkc (efbxprxemu )	Positive	24 Oct 2023
NCT04392154 (ADjoin, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	-	Lebrikizumab 250 mg Monthly (Q4W) (ADvocate 1&2 → ADjoin)	jrocnsvjpb(zmhgufazan) = Less than three percent of patients experienced AEs leading to treatment discontinuation jsdzxxxtzo (vqufojzkkd )	Positive	20 Oct 2023
				Lebrikizumab 250 mg Every two weeks (Q2W) (ADvocate 1&2 → ADjoin)
ADvocate1&2, ADjoin (EADV2023)	Phase 3	Alzheimer Disease	-	Lebrikizumab 250 mg every two weeks (LEB Q2W)	usdaoktkiz(scizinexgy) = evmnbrqcky ushzernfvj (clwhfznzth )	-	11 Oct 2023
				Lebrikizumab every 4 weeks (LEB Q4W)	usdaoktkiz(scizinexgy) = fgvcrlsoif ushzernfvj (clwhfznzth )
NCT05149313 (ADvantage, EADV2023)	Phase 3	Eczema \| Dermatitis, Atopic	331	Lebrikizumab + Topical Corticosteroids	zgwjvtstsp(wznkvkanex) = hyltxbuftp nllpupwcfw (jxsktpndfn ) View more	Positive	11 Oct 2023
				Placebo + Topical Corticosteroids	zgwjvtstsp(wznkvkanex) = hrnxgflkhx nllpupwcfw (jxsktpndfn ) View more
EADV2023	Phase 3	Dermatitis, Atopic	-	Lebrikizumab	hwxqgebhur(knnkbrqtrs) = tecyvdhsdr mtjrewvlbt (zljokdgach ) View more	-	11 Oct 2023
				Placebo	hwxqgebhur(knnkbrqtrs) = okpfjjvzoo mtjrewvlbt (zljokdgach ) View more
ADvocate1 and ADvocate2 (EADV2023)	Phase 3	-	851	Lebrikizumab 250 mg Q2W	aahvvfdgqg(jvoolsrysg) = lnmpscjxel gstopmdwmv (tcqfbioiae ) View more	-	11 Oct 2023
EADV2023	Not Applicable	Dermatitis, Atopic	-	Lebrikizumab	adzqhmiccy(ivkzidzvhu) = ecgqyrnahi xpugjpcnyc (jrvywnjxsg ) View more	-	11 Oct 2023
				Placebo	adzqhmiccy(ivkzidzvhu) = ejiuitskzz xpugjpcnyc (jrvywnjxsg ) View more
Phase 3 (EADV2023)	Phase 3	Dermatitis, Atopic	-	Lebrikizumab	fzukhanhgx(nvewukqjvz) = zwfhousual dseepksruh (pxuchoeymq ) View more	Positive	11 Oct 2023
				Placebo	fzukhanhgx(nvewukqjvz) = ciunzywcoz dseepksruh (pxuchoeymq ) View more
EADV2023	Phase 3	Dermatitis, Atopic Adjuvant	-	Lebrikizumab	jmndaeqrte(upvqezklln) = jjlceweguv qlhkzepdas (cjcaiwzkxb ) View more	-	11 Oct 2023
				Placebo	jmndaeqrte(upvqezklln) = lecakammxh qlhkzepdas (cjcaiwzkxb ) View more