Lebrikizumab
- Generic Name
- Lebrikizumab
- Brand Names
- Ebglyss
- Drug Type
- Biotech
- CAS Number
- 953400-68-5
- Unique Ingredient Identifier
- U9JLP7V031
- Background
Lebrikizumab has been used in trials studying the treatment of Asthma, Allergic Asthma, Atopic Dermatitis, Idiopathic Pulmonary Fibrosis, and COPD, Chronic Obstructive Pulmonary Disease.
Eli Lilly Reports Doubled Q4 Profits Driven by Surging Obesity and Diabetes Drug Sales
• Eli Lilly's Q4 net income soared to $4.4 billion, doubling from $2.2 billion year-over-year, propelled by strong performance of Mounjaro and Zepbound in the diabetes and obesity markets.
• Mounjaro sales surged 60% to $3.5 billion in Q4, while the newly launched Zepbound generated $1.9 billion in revenue, marking significant growth in the incretin drug market.
• The company projects 2025 non-GAAP earnings of $22.50-$24.00 per share and plans to increase incretin drug production capacity by at least 60% in the first half of 2025.
FDA Approvals and Clinical Trials Signal Growth for Eli Lilly
Eli Lilly has recently gained FDA approval for Omvoh, a treatment for Crohn's disease, and Kisunla, aimed at early-stage Alzheimer's patients. These approvals, based on promising clinical trial results, are expected to significantly contribute to the company's growth, with Omvoh potentially reaching over $2 billion in annual sales and Kisunla expected to exceed $7 billion.
Novel Therapies to Watch in 2025: Oncology, Hematology, and Neurology
• Tarlatamab (Imdelltra) is set to transform small cell lung cancer treatment, targeting DLL3-expressing cells and potentially becoming the standard of care for previously treated ES-SCLC.
• Fitusiran, an antithrombin-targeting siRNA, offers a novel approach to hemophilia A or B treatment, demonstrating significant reductions in annualized bleeding rates in phase 3 trials.
• Vepdegestrant (ARV-471), a PROTAC protein degrader, shows promise in ER+/HER2- metastatic breast cancer, potentially offering a more effective protein degradation mechanism.
• Cobenfy (xanomeline and trospium chloride) represents a new class of schizophrenia treatment, selectively targeting M1 and M4 receptors, with observed improvements in clinical trials.
FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease
• The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults, expanding its use for inflammatory bowel disease.
• The approval was based on the VIVID-1 trial, which showed significant clinical remission and endoscopic response rates compared to placebo after one year of treatment.
• Omvoh is the first biologic in over 15 years with Phase 3 two-year efficacy data at launch, demonstrating long-term disease control and visible healing of the intestinal lining.
• Lilly has submitted marketing applications globally, aiming to provide a new treatment option for Crohn's patients and is working with insurers to enable patient access.
Lebrikizumab Shows Promise for Long-Term Management of Atopic Dermatitis in Phase 3 Trial
• Phase 3 trial data demonstrates lebrikizumab's efficacy in managing atopic dermatitis (AD) symptoms over 52 weeks, a significant improvement over the 16-week maintenance shown in previous trials.
• Lebrikizumab, a monoclonal antibody inhibiting IL-13, shows potential for reducing skin inflammation and itch, key symptoms of AD, with infrequent dosing options.
• The most common side effects reported in the trial were mild and manageable, including conjunctivitis, common cold, and headaches, without leading to treatment discontinuation.
• Almirall and Lilly plan to submit regulatory applications to the EU and US, respectively, with potential launch expected after approval in 2023, offering a new first-line systemic treatment option.
Galderma's Nemolizumab (Nemluvio) Receives FDA Approval for Moderate-to-Severe Atopic Dermatitis
• The FDA has approved Nemluvio (nemolizumab) for moderate-to-severe atopic dermatitis in patients 12 years and older when topical treatments are inadequate.
• Nemolizumab is the first monoclonal antibody targeting IL-31 receptor alpha, offering a novel approach to reduce itch and inflammation associated with atopic dermatitis.
• Clinical trials showed significant improvements in skin clearance, itch relief, and sleep disturbance with nemolizumab in combination with topical treatments.
• Galderma anticipates peak sales of nemolizumab to exceed $2 billion, with potential blockbuster status by the end of 2027.
Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial
• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial.
• The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users.
• Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy.
• The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.
FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions
• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity.
• Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors.
• Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors.
• Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
Lilly's EBGLYSS Demonstrates Efficacy in Atopic Dermatitis Patients Unresponsive to Dupilumab
• Eli Lilly's EBGLYSS demonstrated significant improvements in skin condition and itch relief in moderate-to-severe atopic dermatitis patients who had an inadequate response to dupilumab.
• In the Phase IIIb ADapt study, 57% of patients achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) score by week 16, increasing to 60% by week 24.
• More than half of the patients experienced significant itch relief, with 53% at week 16 and 62% at week 24 showing at least a four-point improvement from baseline.
• Clear or almost clear facial dermatitis was observed in 52% of patients treated with EBGLYSS by week 24, with a safety profile consistent with prior Phase III trials.
Lebrikizumab Shows Promise in Atopic Dermatitis, Including After Dupilumab Discontinuation
• Lebrikizumab (Ebglyss) is FDA-approved for moderate to severe atopic dermatitis in adults and children 12 years and older who haven't responded to topical treatments.
• Clinical trials (ADvocate 1, ADvocate 2, and ADhere) demonstrated significant skin clearance and itch relief with lebrikizumab compared to placebo.
• A phase 3b study (ADapt) showed lebrikizumab's efficacy in patients who previously discontinued dupilumab due to inadequate response or intolerance.
• The ADapt study reported significant improvements in skin condition and quality of life, with manageable adverse events, offering a valuable option for those failing dupilumab.
Fall Clinical 2024: Leqselvi Shows Promise in Alopecia Areata, Ebglyss Demonstrates Efficacy in Eczema
• Sun Pharma presented long-term data on Leqselvi 8 mg tablets, demonstrating significant scalp hair regrowth in patients with severe alopecia areata.
• Adbry achieved EASI-75 in 92.9% and IGA 0/1 in 66.7% of atopic dermatitis patients, showcasing a strong efficacy and safety profile.
• A phase 3b study revealed that Ebglyss reduced eczema severity and itch in challenging areas, with 60% of prior dupilumab patients showing key improvements by week 24.
• Rocatinlimab's effect on SCORAD scores across baseline characteristic subgroups in adults with moderate to severe atopic dermatitis was detailed in a poster presentation.
Ebglyss Shows Promise in Eczema Patients Unresponsive to Dupixent
• Eli Lilly's Ebglyss (lebrikizumab) demonstrated significant improvements in skin clearance and itch reduction in patients with moderate-to-severe atopic dermatitis.
• In a Phase 3b study, 57% of patients achieved a 75% improvement in EASI score at 16 weeks with Ebglyss after prior Dupixent treatment.
• Ebglyss also improved hand and face dermatitis, with 52% of patients showing clear or almost clear facial skin at Week 24.
• The FDA approved Ebglyss for atopic dermatitis in adults and children 12+ who weigh at least 88 pounds.
Ebglyss Approval Boosts Eli Lilly's Dermatology Portfolio Amidst Strong Growth
• Eli Lilly's Ebglyss (lebrikizumab) received FDA approval in September for treating moderate-to-severe atopic dermatitis (eczema) in adults who haven't responded to topical treatments.
• Ebglyss is an injectable medication, offering an alternative to creams and ointments for patients with persistent eczema symptoms like dry skin and itchiness.
• The global atopic dermatitis treatment market is projected to reach $31.4 billion by 2034, with North America expected to be a significant contributor.
• Eli Lilly's stock performance has been strong in 2024, driven by successes in diabetes, obesity, Alzheimer's, and now dermatology with Ebglyss.
FDA Approves Bimzelx for Psoriatic Arthritis and Spondyloarthritis; New Eczema Treatment Ebgliss
• The FDA has approved Bimzelx (bimekizumab-bkzx) for psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, targeting IL-17A and IL-17F to reduce inflammation.
• Eli Lilly's Ebgliss (lebrikizumab-lbkz) has been approved by the FDA for moderate-to-severe eczema in patients 12 and older, showing skin clearance and itch relief in studies.
• A new study indicates that osteoporosis and fracture rates have significantly decreased in rheumatoid arthritis patients over the past 24 years due to advances in treatments like biologics.
• Research suggests that moderate coffee consumption (3 cups/day) may lower the risk of heart disease, stroke, and type 2 diabetes due to antioxidants and anti-inflammatory agents.
Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease
• Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment.
• The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients.
• Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden.
• Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.
FDA Approves Eli Lilly's Ebglyss (Lebrikizumab) for Moderate-to-Severe Atopic Dermatitis
• The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in patients 12 years and older.
• Ebglyss, a targeted IL-13 inhibitor, offers a new first-line biologic option for patients whose eczema is not well-controlled with topical treatments.
• Clinical trials demonstrated that Ebglyss significantly improved skin clearance and itch relief, with many patients maintaining results after one year.
• Ebglyss is expected to be available in the U.S. in the coming weeks, with Lilly offering patient support programs to ensure access.
September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases
• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback.
• Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data.
• Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC).
• Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.
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