Budesonide/Formoterol fumarate/Glycopyrronium Bromide

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

Nucala made its debut in 2015 with an FDA approval for severe asthma. Since then, the GSK antibody has racked up a series of respiratory nods—though none yet in COPD. GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim.On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years.In turn, the MATINEE trial, which pitted Nucala against placebo, met its primary endpoint, GSK said in a release.While detailed data were not presented in GSK’s announcement, the British drugmaker said it plans to share the full results of the study at a future medical conference. GSK added that it will use those data to “inform ongoing discussions with regulatory authorities” about a potential Nucala label expansion. Nucala made its debut in 2015 with an FDA approval for severe asthma. Since then, the antibody has racked up a series of respiratory nods, including for Churg-Strauss Syndrome, severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps.Still, Nucala could be looking at a big opportunity in COPD, which GSK estimates affects more than 300 million people around the world. Up to 40% of those patients display type 2 inflammation marked by raised blood eosinophil count, which in turn drives disease exacerbations that can cause lung damage, progressive lung function decline and risk of hospitalization.Since IL-5 is a key messenger protein in type 2 inflammation, GSK figures its respiratory stalwart could be a good fit for many of those patients.GSK’s MATINEE trial—which is one of three testing Nucala in COPD—recruited patients with broad clinical presentations of chronic bronchitis and/or emphysema who were already being treated with inhaled maintenance therapy. Patients in the study also had to have evidence of type 2 inflammation marked by raised blood eosinophil count.COPD prevents airflow to the lungs and causes breathing problems. The condition, which is a leading cause of death in the U.S., according to the CDC, is mainly caused by smoking, though nonsmokers are also susceptible. Nucala is the crown jewel in GSK’s respiratory franchise and brought home 1.65 billion pounds sterling ($2.2 billion) for all of 2023. In 2024’s second quarter, the antibody generated 482 million pounds ($635.7 million), growing 17% at constant currencies over the sum it drew in during the same period last year.GSK is rekindling its COPD bid for Nucala after the FDA rebuffed the drug in the condition back in 2018, echoing the opinions of an advisory panel that had previously questioned whether there were enough data to approve the antibody in patients with high eosinophil levels.At the time, the setback marked the end of a long-running COPD race between Nucala and AstraZeneca’s own IL-5 antibody Fasenra. Earlier that same year, AZ disclosed that Fasenra had failed in a phase 3 trial—the second of two—in patients with moderate to very severe COPD.The trial flopped halted Fasenra’s trajectory in COPD, though AZ has since had luck with other medications, such as the triple combination inhaled corticosteroid Breztri, which passed muster with the FDA as a COPD maintenance treatment in 2020.Earlier this year, AZ and its partner Amgen reported mixed data on their asthma drug Teszpire in the condition. In the phase 2a COURSE study, Tezspire failed to meet its primary endpoint but did show the effectiveness of the antibody in certain patients with COPD. As GSK builds the case for Nucala in COPD, one would-be rival—Sanofi and Regeneron’s Dupixent—recently hit a snag in the disease in the U.S.In late May, the partners revealed that the FDA had pushed back its planned decision date for a potential Dupixent COPD approval to Sept. 27. The regulatory decision, while disappointing, wasn’t a complete surprise, as Regeneron said earlier that same month that the FDA had requested additional data from two trials positioning Dupixent for a potential label expansion in COPD.The very same day Sanofi and Regeneron revealed their setback at the FDA, Europe’s drug regulator recommended Dupixent for approval to treat the respiratory illness. Meanwhile, Verona Pharma in June received a thumbs up from the FDA for its COPD maintenance treatment Ohtuvayre (ensifentrine) in adults. At the time, Verona touted its drug—which inhibits the PDE3 and PDE4 enzymes—as the first inhaled COPD product with a novel mechanism of action for maintenance treatment in more than 20 years.Verona added that it was “fully staffed to launch” and said it expects Ohtuvayre to hit the U.S. market in the third quarter through a network of specialty pharmacies. Editor's note: This story has been updated with additional background on Nucala's development in COPD.