GR agonists(Glucocorticoid receptor agonists), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases

Active Indication

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema+ [4]

Inactive Indication-

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca PLC

Pearl Therapeutics, Inc.Astrazeneca Dunkerque Production SCS

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (18 Jun 2019),

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema

Regulation-

Structure

Molecular FormulaC25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS Registry51333-22-3

View All Structures (3)

Clinical Trials associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

NCT06531798 / Not yet recruitingPhase 4

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

Start Date01 May 2025

Sponsor / Collaborator

AstraZeneca PLC

NCT06723756 / Not yet recruitingPhase 1

A Phase I, Randomized, Double-blind, Single-dose, Partial Replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA in Healthy Adult Participants

This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.

Start Date23 Jan 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT06712563 / Not yet recruitingNot Applicable

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

Start Date13 Jan 2025

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Translational Medicine associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Patents (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

Literatures (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

01 Dec 2024·ADVANCES IN THERAPY

Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA)

Article

Author: Argoubi, Ramzi ; Yoshida, Yuri ; Müllerová, Hana ; Makita, Naoyuki ; Takahashi, Koichiro ; Issa, Seham ; Castañeda-Sanabria, Johann ; Nowacki, Grégoire ; Matsumoto, Isao

INTRODUCTION:

In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies.

METHODS:

This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018-December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated ≤ 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users.

RESULTS:

A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with ≥ 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0-14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common.

CONCLUSION:

Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease.

01 Nov 2024·AMERICAN JOURNAL OF MEDICINE

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study

Article

Author: Müllerová, Hana ; Hawkins, Nathaniel M ; Vogelmeier, Claus F. ; Rhodes, Kirsty ; Vogelmeier, Claus F ; Marshall, Jonathan ; Pollack, Michael ; Anzueto, Antonio ; Hawkins, Nathaniel M. ; Rapsomaniki, Eleni

BACKGROUND:

Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiopulmonary and mortality risk, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce cardiopulmonary risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes with SITTs versus multiple inhaler triple therapies (MITTs).

METHODS:

SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's de-identified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.

RESULTS:

In the primary cohort, risk (hazard ratio [95% confidence intervals]) of all-cause mortality and a first severe cardiopulmonary event were 18% (0.82 [0.75, 0.91]) and 12% (0.88 [0.83, 0.93]) lower in patients initiating BGF versus MITT; results were consistent across censoring definitions, landmark periods, and sensitivity cohorts.

CONCLUSION:

In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics, supporting the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management.

01 Oct 2024·MOLECULAR NUTRITION & FOOD RESEARCH

Garlic Bioconverted by Bacillus subtilis Stimulates the Intestinal Immune System and Modulates Gut Microbiota Composition

Article

Author: Suh, Hyung Joo ; Lee, Sanghyun ; Kim, Kwang Bin ; Jeong, Hyeleen ; Moon, Sung‐Kwon ; Yu, Hyeonjun ; Tonog, Genevieve ; Kim, Hae Soung ; Kim, Hoon

Scope:

This study evaluates the potential of bioconverted garlic ferments (BGFs) to stimulate the intestinal immune system and modulate cecal microbiota composition.

Methods and results:

In vitro, BGF significantly enhances Peyer's patch (PP)‐mediated bone marrow cell proliferation and increases the production of interferon‐gamma (IFN‐γ), granulocyte macrophage‐colony stimulating factor (GM‐CSF), interleukin (IL)‐6, and immunoglobulin A (IgA) but not IL‐4, IL‐5, and immunoglobulin E (IgE). Oral administration of BGF to C3H/HeN mice for 4 weeks significantly increases the GM‐CSF (42.1–45.8 pg mL−1) and IFN‐γ (6.5–12.1 pg mL−1) levels in PP cells. BGF also significantly elevates the levels of tumor necrosis factor‐alpha (TNF‐α, 165.0–236.3 pg mg−1), GM‐CSF (2.4–3.0 ng mg−1), and IFN‐γ (1.5–3.2 ng mg−1) in the small intestinal fluid, and TNF‐α (2.2–3.1 pg mL−1) and IFN‐γ (10.3–0.21.5 pg mL−1) in the mouse serum. Cecal microbial analysis reveals that BGF increases Bacteroidota and Verrucomicrobiota and decreases Actinobacteria and Bacillota at the phylum level in mice. At the genus level, BGF significantly increases the abundance of Fusimonas (250 mg kg−1 BW−1 day−1), Bacteroides (125 and 250 mg kg−1 BW−1 day−1), and Akkermansia (125 mg kg−1 BW−1 day−1) and decreases that of Bifidobacterium (62.5 and 250 mg kg−1 BW−1 day−1) and Limosilactobacillus (125 and 250 mg kg−1 BW−1 day−1).

Conclusion:

This study provides the first evidence of BGF's ability to modulate the intestinal immune system and gut microbiota, supporting its potential as a novel functional material to enhance gut immunity.

News (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

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

06 Sep 2024

·www.fiercepharma.com

GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decision

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.

Clinical ResultPhase 3Drug ApprovalPhase 2

12 Aug 2024

·www.fiercepharma.com

AbbVie’s Skyrizi, Rinvoq retake the top TV drug ad spenders’ crown as top climber Rexulti continues strong run

Spending on the top 10 drugs dropped to just $140 million in July. As we hit the middle of the year, AbbVie is comfortably back in the top TV drug ad spenders’ driving seat taking the top two spots in July with its immunology blockbuster duo Skyrizi and Rinvoq, respectively, according to real-time TV trackers at iSpot.TV.In third place in July is Lundbeck and Otsuka’s central nervous system (CNS) Rexulti, but in a surprising twist, Rexulti took the top spot in June away from the dominant force that is AbbVie in 2024 for the second time this year. In July, however, spending shifted dramatically among the top three, with AbbVie bumping up the cash funneled into Skyrizi’s TV ads by nearly $5 million while dropping spend on Rinvoq by $1.4 million.Meanwhile, spending on Rexulti’s ads fell by a massive $6.8 million from June to July, precipitating its drop into third place. In fourth place is Sanofi and Regeneron’s immunology giant Dupixent, with spending up by nearly $2 million month-over-month. However, its days of challenging AbbVie as the largest TV drug ad spender appear to be over for now.In fifth is Eli Lilly and Boehringer Ingelheim’s diabetes treatment Jardiance. In the sixth position, up one spot from last month is Novo Nordisk’s injectable GLP-1 diabetes drug Ozempic.AbbVie returns with its bipolar and MDD drug Vraylar in seventh place, making it the most prolific top 10 member for July. In eighth is Amgen’s plaque psoriasis and psoriatic arthritis drug Otezla, which has ad hoc appearances in these lists. AstraZeneca’s respiratory disease treatment Breztri Aerosphere continues its mini-run in the top 10 this year, coming in ninth place.Rounding off the top 10 is Merck’s cancer megablockbuster Keytruda, an unusual entrant given how seldom pharma taps TV for oncology meds.In July, we saw the top 10 pharma drug spenders funnel just over $140 million into TV drug ads, down from the already low $151.7 million in June. This is a major drop from the around $190 million in spending we saw in April and May, showing a significant slowdown in spending as we head into the dog days of summer.Check out the top 10 below from iSpot.TV below.1. SkyriziMovement: Up two spotsWhat is it? AbbVie’s immunology drugEst. national TV ad spend: $28.3 million (up from $23.5 million in June)Number of spots: 10 (two psoriatic arthritis, six psoriasis, two Crohn’s disease)Biggest-ticket ad: “Sailing: $0 per Treatment” (est. $8.9 million)2. RinvoqMovement: No changeWhat is it? AbbVie’s JAKi immunology drugEst. national TV ad spend: $22.5 million (down from $23.9 million in June)Number of spots: Eight (two UC/Crohn’s, four arthritis, two eczema)Biggest-ticket ad: “Just Okay: Hiker and Event Planner” (est. $5.1 million)3. RexultiMovement: Down two spotsWhat is it? Otsuka and Lundbeck’s CNS drugEst. national TV ad spend: $18.3 million (down from $25.5 million in June)Number of spots: Two (one depression, one Alzheimer’s)Biggest-ticket ad: “Mom's Alzheimer's” (est. $10.7 million)4. DupixentMovement: No changeWhat is it? Sanofi and Regeneron’s immunology drugEst. national TV ad spend: $17.9 million (up from $15 million in June)Number of spots: Seven (two asthma, five eczema)Biggest-ticket ad: “This Is Better” (est. $6.9 million)5. JardianceMovement: No changeWhat is it? Eli Lilly and Boehringer Ingelheim’s diabetes treatmentEst. national TV ad spend: $11.5 million (down from $13.1 million in June)Number of spots: TwoBiggest-ticket ad: “Musical: Garden” (est. $7.9 million)6. OzempicMovement: Up one spotWhat is it? Novo Nordisk’s injectable GLP-1 diabetes drugEst. national TV ad spend: $10.1 million (down from $11 million in June)Number of spots: TwoBiggest-ticket ad: “Discover the Ozempic Tri-Zone: Rock Climbing” (est. $5.4 million)7. VraylarMovement: Up one spotWhat is it? AbbVie’s bipolar and MDD drugEst. national TV ad spend: $9.3 million (down from $10.2 million in June)Number of spots: ThreeBiggest-ticket ad: “A Lift: Home” (est. $5.1 million)8. OtezlaMovement: Not listed last monthWhat is it? Amgen’s plaque psoriasis and psoriatic arthritis drugEst. national TV ad spend: $7.9 million (up from $7.2 million in June)Number of spots: TwoBiggest-ticket ad: “Spotlight” (est. $6 million)9. Breztri AerosphereMovement: Up one spotWhat is it? AstraZeneca’s respiratory disease treatmentEst. national TV ad spend: $7.3 million (down from $8.5 million in June)Number of spots: OneBiggest-ticket ad: “Road trip” (est. $7.3 million)10. KeytrudaMovement: Not listed last monthWhat is it? Merck’s oncology drugEst. national TV ad spend: $6.9 million (down from $7.1 million in June)Number of spots: FiveBiggest-ticket ad: “Known For: Dreams, Tradition, New Places: 17 Types” (est. $2.8 million)

Financial Statement

100 Deals associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

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KEGG	Wiki	ATC	Drug Bank
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Approved

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Indication	Country/Location	Organization	Date
Bronchitis, Chronic	JP	AstraZeneca KK	18 Jun 2019
Pulmonary Disease, Chronic Obstructive	JP	AstraZeneca KK	18 Jun 2019
Pulmonary Emphysema	JP	AstraZeneca KK	18 Jun 2019

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	US	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	JP	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	AR	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	BE	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	BG	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	CA	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	CL	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	HU	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	IN	AstraZeneca PLC	15 Dec 2020
Asthma	Phase 3	IT	AstraZeneca PLC	15 Dec 2020

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Budesonide/Glycopyrrolate/Formoterol (BGF)	nxxbkhjpgy(mvimmlubeq) = cezkwakkni xppcwrjmdf (exejsknvng )	-	19 May 2024
				Multiple Inhaler Triple Therapy (MITT)	nxxbkhjpgy(mvimmlubeq) = jekwedthmv xppcwrjmdf (exejsknvng )
ATS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	aosckkxqhx(mnhyemopvi): HR = 0.61 (95% CI, 0.38 - 0.95), P-Value = 0.030	-	21 May 2023
				Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
ATS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Prompt BGF initiation (≤30 days)	uolcdewrcc(nexpdpvdnw) = wrjmadpywi cjdwpsgith (rgtfaxdxgf, 0.04 - 0.09) View more	-	21 May 2023
				Delayed BGF initiation (31-180 days)	uolcdewrcc(nexpdpvdnw) = ddafmwwfyy cjdwpsgith (rgtfaxdxgf, 0.06 - 0.10) View more
NCT02497001 (Pubmed)	Phase 3	Severe chronic obstructive pulmonary disease	1,902	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	kownfdzyjw(rfregsyzch) = urrrwlujgm ookojperme (ajzkvbadbj ) View more	-	01 Sep 2022
				Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA)	kownfdzyjw(rfregsyzch) = ekmitolydn ookojperme (ajzkvbadbj ) View more
NCT03836677 (Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Budesonide/glycopyrrolate/formoterol fumarate	xrwoiaktzl(kxnyfovggd): GM = 1.09 (95% CI, 1.03 - 1.16)	-	01 Jul 2021
				Glycopyrrolate/formoterol fumarate
NCT02497001 (KRONOS, Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,896	Budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI)	ojgmzfszfw(hgfplkoqoc) = wozbmtdirb hqmhlrxllk (wnzudjuipi )	-	28 Jun 2021
				Budesonide/formoterol fumarate dihydrate (BFF) MDI	ojgmzfszfw(hgfplkoqoc) = dolmwlowal hqmhlrxllk (wnzudjuipi )
ATS2021	Not Applicable	Severe chronic obstructive pulmonary disease	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/18/9.6 µg	zehmymrqhw(stupjndxnb) = rqeiglyduk efyqlokdnl (qnoenelgbk ) View more	-	03 May 2021
				Long-Acting Muscarinic Antagonist/Long-Acting β2-Agonist (LAMA/LABA)	zehmymrqhw(stupjndxnb) = fufcatrgio efyqlokdnl (qnoenelgbk ) View more
NCT02536508 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	627	Budesonide Gylcopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 ug)	xypqiqjhlh(vedofkfxeg) = kesredkdpt cuxxkpnajs (eyrojtcrzl, yjixxkpsie - msfrssintw) View more	-	26 Feb 2021
				Glycopyrronium+Formoterol Fumarate (GFF MDI 14.4/9.6 ug)	xypqiqjhlh(vedofkfxeg) = twkpamgiif cuxxkpnajs (eyrojtcrzl, qrastoucxe - cblssslvsc) View more
NCT02465567 (ETHOS, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	8,588	Budesonide+Glycopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 μg)	fyrnagzjkt(grdddznoki) = aveofccrzg jrwemhixhs (hcopmdxvpe, rkqifgngey - ljtwtwpgpn) View more	-	02 Feb 2021
				BGF (BGF MDI 160/14.4/9.6 μg)	fyrnagzjkt(grdddznoki) = bxpexbshqm jrwemhixhs (hcopmdxvpe, lmjyunyrtp - ferzuuduge) View more
NCT03075267 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	96	PT010 (BGF MDI) 320/14.4/9.6 µg (PT010 (BGF MDI) 320/14.4/9.6 µg)	rducmqfimr(uackbpgiyx) = xhjzfgietv sjxrozywvy (vhvljalpip, sgmsltfsfo - qaidfsptog) View more	-	19 Jan 2021
				PT010 (BGF MDI) 160/14.4/9.6 µg (PT010 (BGF MDI) 160/14.4/9.6 µg)	rducmqfimr(uackbpgiyx) = sofuxoxjvi sjxrozywvy (vhvljalpip, kslopsinqr - iyxlbwkllr) View more

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