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-

CTR20242248 / RecruitingPhase 3

一项在嗜酸性粒细胞增多综合征（HES）患者中评价Benralizumab的有效性和安全性的多中心、随机、双盲、平行组、安慰剂对照、24周、III期研究（包含开放性扩展期）

[Translation] A multicenter, randomized, double-blind, parallel-group, placebo-controlled, 24-week, phase III study (including an open-label extension phase) to evaluate the efficacy and safety of benralizumab in patients with hypereosinophilic syndrome (HES)

评价Benralizumab对嗜酸性粒细胞增多综合征（HES）患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of benralizumab in patients with hypereosinophilic syndrome (HES)

Start Date02 Sep 2024

Sponsor / Collaborator

AstraZeneca AB

[+2]

100 Clinical Results associated with Benralizumab

100 Translational Medicine associated with Benralizumab

100 Patents (Medical) associated with Benralizumab

787

Literatures (Medical) associated with Benralizumab

01 Jan 2025·Joint Bone Spine

Update on targeted treatments for ANCA-associated vasculitis

Article

Author: Puéchal, Xavier

Targeted therapy has revolutionized the management of ANCA-associated vasculitis (AAV) over the last fifteen years. Rituximab, an approved induction and maintenance agent for severe AAV, is no less effective than cyclophosphamide as induction therapy and particularly useful in relapsing or refractory disease, or in women. In patients with relapsing AAV, granulomatosis with polyangiitis or PR3-ANCA, it is more effective than cyclophosphamide. Rituximab maintenance is superior to the conventional immunosuppressive drugs that it replaces. Low-dose preemptive rituximab infusions are recommended every 6months for 18months, followed by re-evaluation to decide whether 4 additional biannual infusions should be administered, balancing the probability of relapse and the risk of serious infections on rituximab. A growing body of experimental and clinical data shows that C5a pathway inhibition is a promising therapeutic option for AAV, which could reduce glucocorticoids needs. Avacopan is a first approved oral C5A receptor antagonist, used when there is a high risk that glucocorticoids will cause serious adverse events. In eosinophilic granulomatosis with polyangiitis, the importance of IL-5 for eosinophil activation and survival led to evaluation and approval of mepolizumab, a humanized monoclonal antibody directed against IL-5. Mepolizumab showed a steroid-sparing effect. Its effectiveness in active vasculitis remains uncertain and is currently being evaluated. Benralizumab targeting the IL-5 receptor was recently shown to be noninferior to mepolizumab. Rituximab has had disappointing results in non-severe active vasculitis and is being evaluated as maintenance therapy. Plasma exchange is not indicated as first-line treatment but remains recommended when creatinine levels exceed 300μmol/L.

31 Dec 2024·Annals of Medicine

Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis

Article

Author: Martínez-Colls, Mimar ; Cardona Peitx, Gloria ; Pardo, Laura ; Basagaña, Maria ; Abad, Jorge ; Carabias, Lídia ; Padró, Clara ; Cruz, Paula ; Garcia-Olivé, Ignasi ; Navarro, Juan ; Roger, Albert ; Rosell, Antoni ; Martínez-Rivera, Carlos

BACKGROUNDSome patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients' characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice.METHODSData of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV₁ >80% predicted.RESULTSAn improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern.CONCLUSIONSThis study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.

31 Dec 2024·Annals of Medicine

Improvement in health-related quality of life questionnaires with biologic treatment in severe asthma and comorbid chronic rhinosinusitis with or without nasal polyposis: a real-life experience

Article

Author: Santus, Pierachille ; Lorusso, Rosaria ; Busatto, Paolo ; Milani, Lisa ; Casartelli, Anna ; Saad, Marina ; Radovanovic, Dejan ; Danzo, Fiammetta

BACKGROUNDPatients with severe asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, that can increase the symptom burden and complicate treatment. Real-life clinical data on the impact of biologic treatments on CRS-specific quality-of-life questionnaires are still lacking.MATERIALS AND METHODSIn this retrospective real-life study, we collected data from patients with severe asthma with comorbid CRS with/without nasal polyposis at baseline, and after 3, 6 and 12 months of treatment with omalizumab, mepolizumab, benralizumab or dupilumab. In particular, we evaluated improvements in HRQoL as measured by SinoNasal Outcome Test-22 (SNOT-22, 0 - 110), Visual Analog Scale symptom scores (VAS, 0-10), and Asthma Control Test (ACT, 5-25) and the proportion of patients meeting the minimal clinically important difference (MCID).RESULTSDisease-specific HRQoL, as measured by SNOT 22 and VAS score improved in all patients at 3, 6, and 12 months of treatment compared with baseline (SNOT-22: 14, IQR: 0-52 vs 10, IQR:0-30 vs 0, IQR:0-15 vs 0, IQR:0-12, p < 0.001, VAS score: 1, IQR: 0-5 vs 0, IQR:0-3 vs 0, IQR:0-2 vs 0, IQR 0-1, p < 0.001). After 3 months of treatment >80% of patients reached the MCID for ACT, while only patients on dupilumab showed to reach a MCID in 100% of cases. The effect size depended upon the symptom burden at baseline.CONCLUSIONSThe study confirms the efficacy of omalizumab, mepolizumab, benralizumab, and dupilumab in a real-life setting, with a rapid improvement in CRS-specific HRQoL and general health status. These data highlight the importance of targeting type 2 inflammation in asthmatic patients with co-existing upper and lower airways disease.The Authors disclose that preliminary data and analysis of the present study have been presented in abstract form during the "X International Workshop on Lung Health - Respiratory Disease and Immune Response", held in Nice on 19-21 January 2023.

News (Medical) associated with Benralizumab

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

05 Nov 2024

·pmlive.com

AstraZeneca’s Fasenra approved by EC to treat rare inflammatory disease EGPA

AstraZeneca’s Fasenra (benralizumab) has been approved by the European Commission (EC) to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated inflammatory disease that affects approximately 118,000 people globally. The drug has been specifically authorised by the regulator for use as an add-on treatment for adults with relapsing or refractory disease. Formerly known as Churg-Strauss syndrome, EGPA can result in damage to multiple organs, including the lungs, upper airway, skin, heart, gastrointestinal tract and nerves. Patients are often treated with chronic high-dose oral corticosteroids, but can experience recurrent relapses when they attempt to stop taking them. Fasenra, which is already approved in the EU as an add-on maintenance treatment for severe eosinophilic asthma, is designed to reduce the survival of eosinophils and basophils by interfering with interleukin-5 receptor binding. The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage MANDARA study, in which patients were randomised to receive either a single 30mg subcutaneous injection of Fasenra, or three separate 100mg subcutaneous injections of mepolizumab every four weeks. Almost 60% of Fasenra-treated patients achieved remission, which was comparable to those receiving mepolizumab, and 41% of those being treated with Fasenra were able to fully taper off oral corticosteroids, compared to 26% in the mepolizumab arm. Ruud Dobber, executive vice president, biopharmaceuticals business unit, AZ, said: “[This] approval of Fasenra, with its convenient, single-monthly injection is a positive step forward for patients with EGPA. “Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.” The new authorisation comes less than two months after Fasenra received approval from the US Food and Drug Administration to treat adults with EGPA. The US regulator also approved the drug earlier this year for use in severe eosinophilic asthma patients aged six to 11 years with an eosinophilic phenotype.

Clinical ResultDrug ApprovalPhase 3

29 Oct 2024

·www.pharmaceutical-technology.com

EC approves AstraZeneca’s Fasenra for EGPA treatment

Results from the trial indicate that almost 60% of patients treated with Fasenra achieved remission. Credit: Mr. Ashi. Sae Yang/Shutterstock. The European Commission (EC) has approved AstraZeneca ‘s Fasenra (benralizumab) as an add-on therapy for adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), a condition previously known as Churg-Strauss syndrome. Fasenra is the second biologic approved for the condition. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is supported by results from the MANDARA Phase III study. EGPA is an uncommon, immune-mediated vasculitis that results from inflammation of small to medium-sized blood vessels, potentially causing multi-organ damage. It can be perilous if left untreated. Almost 50% of patients with EGPA also suffer from severe eosinophilic asthma and often experience sinus and nasal symptoms. See Also: Novartis’ Scemblix gains FDA approval for leukaemia GSK to acquire Chimagen’s CMG1A46 for autoimmune disease AstraZeneca bioPharmaceuticals business unit executive vice-president Ruud Dobber stated: “Today’s approval of Fasenra, with its convenient, single-monthly injection, is a positive step forward for patients with EGPA. “Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.” The randomised, double-blinded, active-controlled MANDARA study evaluated Fasenra’s efficacy and safety against mepolizumab in adult subjects with relapsing or refractory EGPA. It marked the first head-to-head non-inferiority trial of biologics in this patient group. The trial enrolled 140 patients, randomised into a 1:1 ratio, who received either a single 30mg subcutaneous injection of Fasenra or three distinct 100mg injections of mepolizumab subcutaneously every four weeks. Almost 60% of patients treated with Fasenra achieved remission, a rate comparable to those treated with mepolizumab. 41% of patients treated with Fasenra completely narrowed down oral corticosteroids (OCS). The safety and tolerability profile in the MANDARA trial was consistent with the medicine’s known profile. Developed by AstraZeneca and in-licensed from BioWa, a subsidiary of Kyowa Kirin , Fasenra is approved in more than 80 countries and regions, including Japan, the US, the EU and China.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Benralizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09874	Benralizumab	R03DX10	DB12023

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Churg-Strauss Syndrome	US	AstraZeneca AB	17 Sep 2024
Severe asthma	US	AstraZeneca AB	17 Sep 2024
Eosinophilic Asthma	NO	AstraZeneca AB	08 Jan 2018
Eosinophilic Asthma	IS	AstraZeneca AB	08 Jan 2018
Eosinophilic Asthma	EU	AstraZeneca AB	08 Jan 2018
Eosinophilic Asthma	LI	AstraZeneca AB	08 Jan 2018
Asthma	US	AstraZeneca AB	14 Nov 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Asthma	NDA/BLA	CN	AstraZeneca AB	14 May 2024
Sinusitis	NDA/BLA	US	AstraZeneca PLC	14 Mar 2022
Severe chronic obstructive pulmonary disease	Phase 1	US	AstraZeneca PLC	13 Jun 2014
Severe chronic obstructive pulmonary disease	Phase 1	JP	AstraZeneca PLC	13 Jun 2014
Severe chronic obstructive pulmonary disease	Phase 1	AT	AstraZeneca PLC	13 Jun 2014
Severe chronic obstructive pulmonary disease	Phase 1	ZA	AstraZeneca PLC	13 Jun 2014
Severe chronic obstructive pulmonary disease	Phase 1	KR	AstraZeneca PLC	13 Jun 2014
Severe chronic obstructive pulmonary disease	Phase 1	CH	AstraZeneca PLC	13 Jun 2014
Severe chronic obstructive pulmonary disease	Phase 1	ES	AstraZeneca PLC	13 Jun 2014
Hypereosinophilic Syndrome	Phase 1	US	AstraZeneca PLC	19 May 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04157348 (MANDARA, FDA_CDER) Manual	Phase 3	Churg-Strauss Syndrome	140	FASENRA	(scklmggxwd) = mrmighxhwy krpncsfean (lripteriys ) View more	Non-inferior	17 Sep 2024
				Mepolizumab	(scklmggxwd) = ccfzfppkty krpncsfean (lripteriys ) View more
NCT01928771 \| NCT01914757 (FDA_CDER) Manual	Not Applicable	Asthma	-	FASENRA (SIROCCO)	(pkynklklxp) = kybchpjwmr nrirkcbrod (wsdrfurfwp )	Positive	17 Sep 2024
				Placebo (SIROCCO)	(pkynklklxp) = elwugjbezw nrirkcbrod (wsdrfurfwp )
NCT04543409 (MESSINA, Pubmed)	Phase 3	Eosinophilic Esophagitis eosinophils	211	Benralizumab 30 mg	cmwsmqozza(pnxqdxvner) = yayqjhmfxw clmwqlentm (ydcehnaidq, 72.9 - 88.8)	Positive	27 Jun 2024
				Placebo	cmwsmqozza(pnxqdxvner) = hfmoouvhhe clmwqlentm (ydcehnaidq )
EULAR2024 Manual	Not Applicable	Eosinophilic Granuloma interleukin 5 (IL-5) \| IL-5α receptor	67	Mepolizumab 300 mg	(pixnvyfdvh) = pxijgfnvdy vktxbattil (ofabblaxxt ) View more	Positive	05 Jun 2024
				Mepolizumab 100 mg	(pixnvyfdvh) = ftokylrryi vktxbattil (ofabblaxxt ) View more
NCT03186209 (CTgov)	Phase 3	Asthma	695	Placebo	ovirqwqslo(njpgmmlboc) = ynylmnazwu cnblrhkaua (rbzgeqjnqi, mwttcyqqem - jpfxahrlwf) View more	-	24 Apr 2024
NCT04612725 (ARROYO, CTgov)	Phase 2	Chronic Urticaria	159	Benralizumab (Benralizumab 30 mg)	jrzngcfhiu(yxfhnbwagf) = xcccnlmgpj inyzcsqvhk (rqobqczgqa, mgyseoqehv - ggrzmegmcr) View more	-	13 Mar 2024
				Benralizumab (Benralizumab 60 mg)	jrzngcfhiu(yxfhnbwagf) = ladurjlxsj inyzcsqvhk (rqobqczgqa, xrdophdjgc - uysjnklxou) View more
NCT04305405 (TATE study, Pubmed) Manual	Phase 3	Eosinophilic Asthma Add-on blood eosinophil count	28	Benralizumab 10 mg/<35 kg	(jtlokkseum) = nyxvbhxkxk esztapykva (kjxsqqqvxb ) View more	Positive	01 Mar 2024
				Benralizumab 30 mg/≥35 kg	(jtlokkseum) = eadjjjpqzs esztapykva (kjxsqqqvxb ) View more
NCT04157348 (MANDARA, Pubmed \| Br Dent J) Manual	Phase 3	Churg-Strauss Syndrome	140	Benralizumab	(tpjebsvuvr) = ddozoxatgv sljqohijop (qqwjadnxjh ) View more	Non-inferior	23 Feb 2024
				Mepolizumab	(tpjebsvuvr) = bxjcpyksjw sljqohijop (qqwjadnxjh ) View more
NCT04157348 (MANDARA, AAAAI2024) Manual	Phase 3	Churg-Strauss Syndrome	-	Benralizumab	(kqirkzxmmj) = tyhpfsaxzs mkereswuro (ucctljkafa ) View more	Positive	23 Feb 2024
				Mepolizumab	(kqirkzxmmj) = nivfiwogvf mkereswuro (ucctljkafa ) View more
AAAAI2024	Not Applicable	Severe asthma FeNO (fractional exhaled nitric oxide)	16	Benralizumab	igsxgbrjka(tfuptpjyui) = xdpsmqgowl xgsqyeptnd (ufikurexkp ) View more	Positive	23 Feb 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis