Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma, Royalty - LARVOL DELTA

Optimizing COPD management in Latin America: a cost-effectiveness analysis of FF/UMEC/VI in Colombia. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Sensitivity analyses confirmed the robustness of results, with FF/UMEC/VI remaining cost-effective in > 60% of simulations. FF/UMEC/VI is a cost-effective strategy for managing moderate-to-severe COPD in Colombia, offering improved clinical outcomes at an acceptable cost and supporting its adoption in treatment guidelines and reimbursement decisions."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Real-World Safety and Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma: Final Analysis of a Post-Marketing Surveillance in Japan. (PubMed, Adv Ther) - "FF/UMEC/VI was well tolerated and effective in the treatment of patients with asthma in Japan. ADRs were reported in 8.4% of patients and the incidence of CV events was low. No new safety concerns were identified."

Journal • P4 data • Real-world evidence • Asthma • Cardiovascular • Cough • Dysphonia • Immunology • Pulmonary Disease • Respiratory Diseases

The Centers for Medicare and Medicaid Services on Tuesday announced lower prices on…costly prescription drugs under Medicare… (MSN News) - "Here are the negotiated prices for the drugs, based on a 30-day supply, compared to the 2024 list price:...(i) Trelegy Ellipta, an asthma treatment: $175, down from $654...; (ii) Ofev, for idiopathic pulmonary fibrosis: $6,350, down from $12,622...; (iii) Breo Ellipta, a COPD drug: $67, down from $397."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis

Sundial-COPD: Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (clinicaltrials.gov) - P4 | N=80 | Completed | Sponsor: Baylor Research Institute | Trial completion date: Sep 2023 ➔ Feb 2025 | Not yet recruiting ➔ Completed

Trial completion • Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

GSK reported third quarter 2025 global net sales of approximately $1.0 billion (up 24% vs. the third quarter of 2024) and year-to-date net sales of approximately $2.9 billion (up 13% vs. 2024 year-to-date) (PRNewswire) - "On track to exceed full year (FY) 2025 global net sales of ~$3.4 billion required to trigger $50 million milestone from Royalty Pharma: Approximately $471 million of global net sales required in Q4 2025 to trigger the $50 million milestone; FY 2026 global net sales of ~$3.5 billion required to trigger an additional $100M milestone from Royalty Pharma."

Sales • Sales projection • Chronic Obstructive Pulmonary Disease • Immunology

Evaluating the Budget Impact of Single Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) in Patients With Moderate to Severe Asthma in the Saudi Healthcare System (ISPOR-EU 2025) - "The introduction of FF/UMEC/VI in the management of uncontrolled asthma in the Saudi healthcare system is expected to save costs and reduce healthcare resource utilization. This treatment option may be a valuable consideration for Saudi healthcare payers aiming to optimize asthma management. GSK Funding: Study 224346"

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

From Varices to Viral Infiltrate: Diagnosing CMV Gastritis in a Cirrhotic, Immunocompromised Host (ACG 2025) - "We present a case of biopsy-proven CMV gastritis in a patient with metabolic-associated steatohepatitis (MASH) cirrhosis and chronic B-cell depletion from long-term rituximab therapy.Case Description/ A 68-year-old woman with compensated MASH cirrhosis, morbid obesity, rheumatoid arthritis (on rituximab for 9 years), interstitial lung disease (on fluticasone furoate/umeclidinium/vilanterol), atrial fibrillation on anticoagulation, prediabetes, hypothyroidism, and depression underwent upper endoscopy for variceal screening...Concurrent plasma CMV DNA by NAAT was elevated at 5,530 IU/mL.Given her immunocompromised status, close coordination with the infectious disease team was undertaken, and the patient was initiated on intravenous ganciclovir therapy. This case highlights the importance of maintaining a broad differential diagnosis when evaluating gastric mucosal changes in immunosuppressed patients with cirrhosis...Histologic evaluation remains essential, especially in..."

Atrial Fibrillation • Cardiovascular • CNS Disorders • Cytomegalovirus Infection • Depression • Dermatology • Endocrine Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Portal Hypertension • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • CD68

Exacerbation Reduction in Patients with Asthma Following Escalation to FF/UMEC/VI from ICS/LABA: Retrospective Cohort Study. (PubMed, Pulm Ther) - "In patients who remain uncontrolled despite ICS/LABA treatment, escalating to FF/UMEC/VI is associated with reductions in asthma exacerbations, asthma-related hospitalizations, OCS use, SABA use, and asthma-related medical costs."

Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Sex-Specific Safety Signals of Trelegy Ellipta: A FAERS Pharmacovigilance Analysis. (PubMed, Med Sci (Basel)) - " This FAERS-based analysis indicates distinct sex-specific safety signals for Trelegy Ellipta, particularly in cardiovascular, neuropsychiatric, and steroid-related domains. These findings are hypothesis-generating and highlight the importance of incorporating sex-disaggregated analyses into future pharmacovigilance and clinical studies."

Adverse events • Journal • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Diabetes • Hypertension • Immunology • Infectious Disease • Mood Disorders • Musculoskeletal Diseases • Osteoporosis • Pain • Pneumonia • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology • Sleep Disorder

Visualizing Improvements in Airway Dysfunction After Inhaled Therapy in Patients With Uncontrolled Asthma: A Narrative Review. (PubMed, Adv Ther) - "A recent study evaluating single-inhaler triple therapy in patients with uncontrolled moderate-severe asthma, despite inhaled corticosteroid/long-acting β2-agonist maintenance therapy, demonstrated that daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 200/62.5/25 µg) led to significantly improved 129Xe MRI VDP after only 6 weeks, which was in line with broader central/distal airway function and quality of life improvements. These results highlight the capacity of 129Xe MRI VDP to detect early responses to treatment. In addition, the mechanistic insights provided by 129Xe MRI VDP also indicated that these benefits are likely due to the combination of UMEC (a long-acting muscarinic antagonist) and an efficacious inhaled corticosteroid, addressing undertreated inflammatory bronchoconstriction, helping to restore airway caliber and function that more closely resemble the airways of a healthy individual.Videos available for this article."

Clinical • Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Airway mucus and 129Xe MRI ventilation after single inhaler triple therapy in asthma. (PubMed, ERJ Open Res) - "In participants with GINA4-5 asthma, who had been poorly controlled on ICS/LABA, single-inhaler FF/UMEC/VI resulted in improved VDP and FEV1 at 6-weeks. These improvements persisted 1-year later when airway markers were also significantly improved, consistent with the reversal of airway remodelling."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

The Egyptian Drug Authority approves the launch of “Trelegy Ellipta” — a new hope for patients with chronic obstructive pulmonary disease (COPD) and asthma. (Ahram Online)

Launch non-US • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Comparable Clinical Outcomes with Tiotropium/Olodaterol or Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with COPD and Blood Eosinophil Count ≤300 Cells/μL. (PubMed, Int J Chron Obstruct Pulmon Dis) - "TIO/OLO initiators incurred lower pharmacy costs related to COPD and/or pneumonia than FF/UMEC/VI initiators. These results support treatment recommendations of reserving inhaled corticosteroids for frequent exacerbators and patients with elevated eosinophil counts."

Clinical • Clinical data • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

MUST: 129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Western University, Canada

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

From disease improvement to disease stability in patients with COPD: IMPACT post hoc analysis (ERS 2025) - P3 | "In this high-risk IMPACT population, patients receiving FF/UMEC/VI were more likely to achieve the composite endpoint vs dual therapy. Funding GSK (CTT116855/NCT02164513)."

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Time -to - understand treatment response (ERS 2025) - P3 | "In both comparisons, total event rates continued to diverge throughout follow-up, despite loss of response on first events. T was early (34 days) for UMEC/VI vs. FF/UMEC/VI, with higher eosinophils in T-1 UMEC/VI than in T+1 UMEC/VI or T-1 triple therapy."

Respiratory Diseases

Investigating individual effects of ICS on COPD exacerbations with causal machine learning (ERS 2025) - P3 | "We focused on two treatment comparisons: fluticasone furoate/umeclidinium/vilanterol (FF/U/V, ICS/LAMA/LABA) versus U/V, and FF/V versus U/V... Causal ML models trained for related exacerbation outcomes selected similar, yet also slightly different patient profiles as best responders for FF. Combining models may result in a more complete understanding of individual response."

Clinical • Machine learning • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Reduction of asthma exacerbations after escalation from BUD/FORM or FP/SAL to FF/UMEC/VI (ERS 2025) - "Conclusions Patients who escalate to FF/UMEC/VI from ICS/LABA significantly reduced asthma exacerbations irrespective of prior BUD/FORM or FP/SAL treatment. Funding GSK (300181)."

Asthma • Immunology • Respiratory Diseases

Single-inhaler triple therapy (FF/UMEC/VI) vs FF/VI in Chinese uncontrolled asthma adults (ERS 2025) - P3 | "FF/UMEC/VI 100 µg can further improve lung function vs FF/VI 100 µg, with a small improvement in ACQ-7, in Chinese asthma pts; but this was not observed with FF/UMEC/VI vs FF/VI 200 µg."

Clinical • Asthma • Immunology • Respiratory Diseases

Clinical remission and small airway improvements after one-year FF/UMEC/VI (ERS 2025) - "1-year FF/UMEC/VI (200/62.5/25µg) resulted in improved airway mucus, LA, TAC and VDP and 4- domain clinical remission in 7/15 evaluated participants."

Clinical • Asthma • Immunology • Respiratory Diseases

TETRIS: A 24-month, prospective study to observe clinical outcomes in COPD patients with different treatment journeys in Germany (ERS 2025) - "COPD patients on continuous therapy with FF/UMEC/VI appear to benefit the most in terms of clinical outcomes. Funding GSK (214468)"

Clinical • Clinical data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

On the disposition of airway mucus-plugs in asthma before and after treatment (ERS 2025) - "Treatment of asthma with either anti-IL-5Rα and FF/UMEC/VI significantly reduced mucus burden similar to healthy volunteers. These results support the notion that airway mucus may serve as a treatable trait in asthma."

Asthma • Immunology • Inflammation • Respiratory Diseases

Comparative in-vitro performance evaluation of two fluticasone furoate/ vilanterol/umeclidinium (100/25/62.5 mcg) multi-dose dry powder inhalers (ERS 2025) - "The delivered dose, FPD, MMAD and GSD of fluticasone furoate, vilanterol and umeclidinium delivered by the two devices were similar at specified flow rates, suggesting similar drug delivery into the lungs under ideal conditions using correct inhaler technique."

Preclinical • Respiratory Diseases

ETHA: Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma (clinicaltrials.gov) - P3 | N=31 | Active, not recruiting | Sponsor: Dr. Grace Parraga | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Economic Analysis of New Single-Inhaler Triple Therapies in Patients with COPD in the UK. (PubMed, Int J Chron Obstruct Pulmon Dis) - "At a willingness-to-pay threshold of £20,000 per QALY, the probability of FF/UMEC/VI being cost-effective was 99.9%, 100%, and 99.3% versus BUD320/GLY/FOR, BUD160/GLY/FOR, and BDP/FOR/GLY, respectively. Based on this analysis, FF/UMEC/VI is a dominant (improved outcomes with cost savings) treatment option compared with other SITTs for the treatment of patients with COPD in the UK."

Clinical • HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases