Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

Start Date16 Oct 2024

Sponsor / Collaborator

Xijing Hospital

NCT06501807 / Not yet recruitingNot ApplicableIIT

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

Start Date02 Sep 2024

Sponsor / Collaborator-

CTIS2023-508069-34-01 / RecruitingIIT

Biomarkers for the prediction of individual CRSwNP patients' responses to mepolizumab

Start Date12 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Mepolizumab

100 Translational Medicine associated with Mepolizumab

100 Patents (Medical) associated with Mepolizumab

1,387

Literatures (Medical) associated with Mepolizumab

01 Dec 2025·CURRENT ALLERGY AND ASTHMA REPORTS

Olfactory Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Effect of Treatment with Emphasis on Biological Therapy

Review

Author: Reitsma, Sietze ; Fokkens, Wytske Johanna ; Otten, Josje Janna

PURPOSE OF REVIEW:

Olfactory dysfunction significantly impacts quality of life that affects a majority of the patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The aim of this review is to explore the impact of various treatment regimens on olfactory dysfunction in patients diagnosed with CRSwNP.

RECENT FINDINGS:

Accurate assessment of olfactory dysfunction remains challenging and should incorporate both psychophysical tests and patient-reported outcomes. Patients with CRSwNP appear capable of reliably evaluating their olfactory function. Standard treatment such as intranasal corticosteroids and surgery have limited capability of restoring the sense of smell. Oral corticosteroids have a far greater potency, albeit short-lived and at the cost of adverse events and side effects. Recent studies on registered biological agents- specifically dupilumab, mepolizumab, and omalizumab- indicate their effectiveness in restoring olfactory function in severe CRSwNP. According to meta-analyses and indirect comparisons, dupilumab shows superiority; however, direct comparative studies are necessary.

01 Feb 2025·The journal of allergy and clinical immunology. Global

A RESPONSE to anti–IL-5 therapy in comorbid patients with chronic rhinosinusitis with nasal polyps and severe asthma: Study protocol

Article

Author: Kallinikou, Nadia ; Pfaar, Oliver ; Schleich, Florence ; Hellings, Peter W. ; Bañas-Conejero, David ; Alobid, Isam ; Hellings, Peter ; Taillé, Camille ; Bakakos, Petros ; Constantinidis, Jannis ; Kallinikou, Konstantina ; Howarth, Peter

Background:

Chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma (SA) are 2 frequently coexisting conditions that are, in most cases, associated with eosinophilic inflammation. The concurrence of both diseases has a negative synergistic impact on disease severity and patients' health-related quality of life. Thus, a holistic, collaborative management of these patients is a critical unmet need. Mepolizumab, a systemic anti-IL-5 therapy, has been shown to be effective as an add-on treatment in both SA and CRSwNP, with more literature available on asthma outcomes than on CRSwNP.

Objectives:

The primary objective of the study is to evaluate the real-world effectiveness of mepolizumab in improving the health-related quality of life of comorbid patients at 12 months using the SNOT-22 questionnaire. Secondary objectives include safety and efficacy outcomes of mepolizumab treatment in the 2 populations, which are expected to have variable severity of the respective comorbid conditions.

Methods:

RESPONSE is a European real-world prospective cohort study designed to assess the effectiveness of mepolizumab in 2 cohorts of adult patients: one with SA as primary diagnosis with (secondary diagnosis) comorbid CRSwNP, and another with CRSwNP as primary diagnosis with (secondary diagnosis) comorbid asthma. Up to 350 patients receiving newly prescribed mepolizumab will be followed up for 12 months as per the investigators' standard of care.

Conclusion:

This study will report the effects of anti-IL-5 therapy in both diseases investigated and the respective comorbidity, as well as the consequence of treating milder forms of asthma and CRSwNP with mepolizumab, supporting the emerging evidence on early treatment optimization.

01 Jan 2025·Respiratory Investigation

Biologics treatment for eosinophilic chronic rhinosinusitis complicated by bronchial asthma: Narrative review

Review

Author: Nagano, Tatsuya

There are 4 subtypes of chronic rhinosinusitis (CRS): eosinophilic CRS with nasal polyps (ECRSwNP), ECRS without NPs (ECRSsNP), non-ECRSwNP, and non-ECRSsNP. Most ECRS cases are categorized as ECRSwNP, and the number of patients with ECRSwNP has recently increased. ECRS is associated mainly with helper T-cell type 2 inflammation and eosinophils. Recently, Interleukin-25, -33, or TSLP, helper T-cell type 17, and Group 2 innate lymphoid cells have also been shown to be involved in the molecular mechanism of ECRS. ECRS can lead to several complications including bronchial asthma and/or aspirin intolerance. Conventionally, surgery and corticosteroids have been used to treat ECRS, but biologics have since been applied. Mepolizumab, benralizumab, and tezepelumab have been reported to improve asthma complicated by NPs more than asthma uncomplicated by NPs. Omalizumab, mepolizumab, benralizumab, and dupilumab have been reported to significantly improve Sinonasal Outcome Test-22 scores, nasal polyp scores, and nasal congestion severity in phase III trials. Benralizumab, dupilumab, and tezepelumab have been reported to improve both ECRS and complicated bronchial asthma.

News (Medical) associated with Mepolizumab

10 Dec 2024

·www.pharmaceutical-technology.com

FDA to review GSK’s Nucala for COPD

GSK’s submission is supported by data from the MATINEE study, which assessed the safety and efficacy of the therapy. Credit: Magda Wygralak/Shutterstock. The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala (mepolizumab) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) in individuals with an eosinophilic phenotype. GSK’s submission is supported by data from the MATINEE study, which assessed the therapy’s safety and efficacy. The study involved 804 COPD patients exhibiting type 2 inflammation, as indicated by blood eosinophil count. The study’s diverse patient group included subjects with clinical presentations including emphysema, chronic bronchitis, or a combination of both. MATINEE achieved its primary endpoint, showing that adding mepolizumab to inhaled maintenance therapy significantly reduced the annualised rate of moderate/severe exacerbations compared to placebo, with subjects treated for 52 to 104 weeks. The outcomes are expected to form the basis of regulatory submissions worldwide. Nucala is already approved in the US for four IL-5-mediated conditions, including severe asthma and chronic rhinosinusitis with nasal polyps, but is not currently indicated for COPD treatment anywhere globally. COPD is a global health issue, affecting more than 390 million people, and more than 14 million in the US. Type 2 inflammation is observed in numerous immuno-inflammatory disorders and serves as the fundamental pathology that contributes to symptoms and exacerbations in up to 40% of individuals with COPD. Inflammation is generally identified by measuring blood eosinophil levels, a specific biomarker that can be evaluated through a blood test. This assessment can provide insights into a COPD patient’s likelihood of experiencing exacerbations and worsening of their condition and guide the development of treatment plans. The Prescription Drug User Fee Act (PDUFA) date for the potential new indication is 7 May 2025. In November 2024, the European Commission approved a single-vial, fully liquid presentation of the company’s Menveo vaccine (MenACWY), aimed at protecting against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y.

VaccineClinical ResultDrug ApprovalEmergency Use AuthorizationClinical Study

12 Nov 2024

·www.prnewswire.com

Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape | DelveInsight

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

08 Nov 2024

·endpts.com

Amgen and AstraZeneca share positive results in chronic rhinosinusitis

Amgen and AstraZeneca said on Friday that their asthma drug Tezspire reduced nasal congestion and the size of nasal polyps in patients with a different but sometimes related inflammatory condition. Tezspire, also known as tezepelumab, met its co-primary endpoints in a Phase 3 study for patients with chronic rhinosinusitis with nasal polyps, a condition caused by inflammation of the nasal lining that can lead to loss of smell or pressure in the face. The topline results pit the partners against GSK, which reported positive data for its own experimental antibody depemokimab last month. Tezspire would also contend with a handful of biologics already approved for the condition, including Sanofi and Regeneron’s Dupixent, Genentech and Novartis’ Xolair and GSK’s Nucala. Other patients treated with surgery or oral corticosteroids “have a significant side effect profile,” according to Andrew Menzies-Gow, VP of respiratory and immunology on AstraZeneca’s global biopharmaceutical medical team. While Amgen and AstraZeneca have not released any specific data from the Phase 3 trial, the companies said they will present full results to regulators soon, as well as “at an upcoming medical meeting.” Patients in the trial had failed on standard-of-care intranasal corticosteroids. “Tezepelumab has a unique mechanism of action. It targets right at the top of the inflammatory cascade, so it clearly differentiates in its mechanism from the other available drugs,” Menzies-Gow told Endpoints News on Friday. Pablo Panella, AstraZeneca’s global head of respiratory and immunology, added that “we’ll be able to have a more informed discussion” about competition when the companies are able to share the full data. Tezspire was first approved in 2021 as a subcutaneous treatment for severe asthma, followed by another approval in 2023 for a self-administered formulation in a prefilled pen. AstraZeneca and Amgen will seek approval for both formulations in chronic rhinosinusitis with nasal polyps, as “some patients in the US prefer to be administered the drug at the clinic,” Panella said. The drug generated $653 million in combined 2023 sales for Amgen and AstraZeneca.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Mepolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D04923	Mepolizumab	R03DX09	DB06612

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Granulomatosis With Polyangiitis	CN	GlaxoSmithKline Trading Services Ltd.	19 Nov 2021
Eosinophilic Granuloma	JP	GlaxoSmithKline KK	25 Mar 2020
Eosinophilic Asthma	KR	GSK Plc	01 Apr 2016
Chronic rhinosinusitis with nasal polyps	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Asthma	US	GlaxoSmithKline LLC	04 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	NDA/BLA	US	GSK Plc	09 Dec 2024
Eosinophilia	Phase 3	GB	GSK Plc	07 Sep 2020
Eosinophilic Esophagitis	Phase 3	CN	GSK Plc	29 Aug 2018
Severe asthma	Phase 3	CN	GlaxoSmithKline Trading Services Ltd.	29 Aug 2018
Severe asthma	Phase 3	CN	GlaxoSmithKline (China) Investment Co., Ltd.	29 Aug 2018
Nasal Polyps	Phase 3	US	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	AR	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	AU	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	CA	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	DE	GSK Plc	25 May 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04276233 (PRISM, CTgov)	Phase 4	Asthma \| Eosinophilic Asthma	100	Mepolizumab	tzpxevbiau(hnxwxxidci) = wfyltfkleb unlvaxmnqf (rryncheiic, jmgzqkxxgu - cfgmadjeyv) View more	-	10 Dec 2024
NCT04607005 (MERIT, CTgov)	Phase 3	Nasal Polyps \| Chronic rhinosinusitis with nasal polyps	169	Mepolizumab (Mepolizumab)	wiunfjdtvr(rbsmlojylk) = pzjrlynqcz tvzpquqagy (lacghzbfxr, ossxcztade - pggzugiktx) View more	-	25 Nov 2024
				placebo (Placebo)	wiunfjdtvr(rbsmlojylk) = seguvowwed tvzpquqagy (lacghzbfxr, zlwuvfyzyl - yjeighxthz) View more
NCT00244686 (Pubmed) Manual	Phase 3	Severe asthma	514	Mepolizumab 100 mg SC (Adults/adolescents (≥12 years of age))	mbpzdyuyfp(shitqhidlr) = eatsnxwszr zvwzetpgtx (nlyffdeobt )	Positive	28 Oct 2024
				Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) (Pediatric patients (6-11 years of age))	-
NCT04133909 (MATINEE, NEWS) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Nucala	gnypboeauy(qrtbpeatsk) = The trial met its primary endpoint. akntgfmxoa (ajrzjerphs ) Met View more	Positive	06 Sep 2024
				Placebo
EULAR2024 Manual	Not Applicable	Eosinophilic Granuloma interleukin 5 (IL-5) \| IL-5α receptor	67	Mepolizumab 300 mg	fjktjnudpl(tckcvbpyaz) = bmarhicqnz wpezjkahfg (dqxmsmljyq ) View more	Positive	05 Jun 2024
				Mepolizumab 100 mg	fjktjnudpl(tckcvbpyaz) = fhqcawoxmm wpezjkahfg (dqxmsmljyq ) View more
EULAR2024 Manual	Not Applicable	Churg-Strauss Syndrome Maintenance \| Induction IL-5	48	Mepolizumab	pntguermwv(fzdboettsa) = bvavvvwjic aedlsoggrv (ocxhgkdilb ) View more	Positive	05 Jun 2024
				Mepolizumab (in the remission induction phase for severe EGPA)	pntguermwv(fzdboettsa) = ptpyuvlbyz aedlsoggrv (ocxhgkdilb ) View more
EULAR2024	Not Applicable	Churg-Strauss Syndrome	-	Mepolizumab 300mg	kxrajxiijr(lrmwllxvrm) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. bsrybogdss (dwibbeklgn )	-	05 Jun 2024
EULAR2024	Not Applicable	Churg-Strauss Syndrome Maintenance MPO-ANCA-associated vasculitis (MPO-AAV)	25	MEPOLIZUMAB (Early administration group)	kjggrlwlsf(qasgktbbsh) = 0 in both groups ezourodezw (eadmmbqsej ) View more	Positive	05 Jun 2024
				MEPOLIZUMAB (During maintenance group)
NCT03298061 (LAP/MEA116841, ATS2024) Manual	Phase 3	Granulomatosis With Polyangiitis	100	Mepolizumab	rpmxamgfio(usyvtpqrex) = fhulmwrjxf ncrfkgsedu (inoydegnxw )	Positive	19 May 2024
EHA2024	Not Applicable	Hypereosinophilic Syndrome Second line PDGFRΑ-negative	3	Mepolizumab	qnejudmzxj(oeplwyikde) = frocgszloo lskhpyjkhr (oxjdyzmbda )	Positive	14 May 2024

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