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

Reduction of asthma exacerbations after escalation from BUD/FORM or FP/SAL to FF/UMEC/VI (ERS 2025) - No abstract available

Asthma • Immunology • Respiratory Diseases

Single-inhaler triple therapy (FF/UMEC/VI) vs FF/VI in Chinese uncontrolled asthma adults (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Clinical remission and small airway improvements after one-year FF/UMEC/VI (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Pulmonary Disease • 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) - No abstract available

Preclinical • Respiratory Diseases

Theravance Biopharma, Inc. Sells Remaining Royalty Interest in Trelegy Ellipta to GSK for $225 Million (PRNewswire) - "Theravance Biopharma, Inc...announced that it has entered into a definitive agreement to sell its remaining royalty interest in net sales of Trelegy Ellipta ('Trelegy') to GSK (NYSE: GSK) for $225 million in cash....Theravance Biopharma retains rights to up to $150 million in milestones from Royalty Pharma on Trelegy Ellipta net sales in 2025 and 2026, requiring minimal to no growth over 2024 actuals to be achieved; $225 million from royalty transaction announced today, in addition to the $1.1 billion upfront received in 2022, and up to $200 million in milestones (of which $50 million was received in 2025), brings total potential lifetime value from Trelegy Ellipta monetization efforts to $1.525 billion."

Commercial • Chronic Obstructive Pulmonary Disease

Trelegy Ellipta: Patents delisted for Trelegy Ellipta from Orange Book (Orange Book) - Patent no.s 8511304, 8511304*PED, 9333310, 9333310*PED, 8161968, 8161968*PED

Patent • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Trelegy Ellipta: Newly added patents in Orange Book (Orange Book) - Expiry on Jun 14, 2027, Oct 2, 2027, Feb 5, 2028

Patent • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Effect of Chronic Mucus Hypersecretion on Patients With COPD Achieving and Maintaining Disease Stability With Fluticasone Furoate/Umeclidinium/Vilanterol Versus Budesonide/Formoterol: A FULFIL Post Hoc Analysis (ATS 2025) - P3 | "Based on the SGRQ- and CAT-containing definitions used, twice as many patients receiving FF/UMEC/VI achieved disease stability up to Week 24 compared with BUD/FOR, irrespective of CMH status. Furthermore, patients maintained disease stability for longer with FF/UMEC/VI versus BUD/FOR, regardless of CMH status. These findings support the implementation of disease stability as a treatment target for optimizing patient management in COPD."

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

Unraveling Bronchiolitis Obliterans in Rheumatoid Arthritis (ATS 2025) - "Prior rheumatologic treatments included prednisone, hydroxychloroquine, and methotrexate. She is currently on mycophenolate mofetil and fluticasone furoate/ umeclidinium/ vilanterol inhaler.Earliest computed tomography (CT) scan of the chest in 2013 showed mild diffuse peribronchial wall thickening and mosaic attenuation...Ultimately radiographic pattern of her lung disease was thought to be OB secondary RA; she was started on inhaled fluticasone propionate and azithromycin, with plan for addition of rituximab.DiscussionDiagnosis of OB is complicated by comorbid conditions with overlapping presentations and the varied pulmonary involvement within RA...Optimal treatment of OB is unclear and disease course is often refractory to therapy with poor prognosis. Management includes a combination of inhaled bronchodilator therapy, macrolides, and aggressive immunomodulatory therapy."

Asthma • Cardiovascular • Fibrosis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome

Exacerbation Reduction in Patients With Asthma Following Initiation of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in the United States (ATS 2025) - "Significant reductions in asthma-related exacerbations, as well as lower OCS and SABA use, and reductions in asthma-related ED visits and medical costs were associated with the post-initiation period of FF/UMEC/VI treatment compared with the pre-initiation period. This provides novel, real-world evidence of the benefits of escalation to FF/UMEC/VI from ICS/LABA therapy in patients with asthma in the US, helping to inform treatment decisions in real-world clinical practice."

Clinical • Asthma • Immunology • Respiratory Diseases

Impact of Simultaneous Step-Up to High-Dose Fluticasone Furoate and Addition of Umeclidinium on a Clinical Remission Endpoint in Asthma: CAPTAIN Post Hoc Analysis (ATS 2025) - P3 | "This abstract is funded by: GSK (205715/NCT02924688) Rationale: Clinical remission (CR) is an ambitious and achievable treatment goal in asthma. Both increasing FF dose and adding UMEC contributed to improving clinical outcomes in patients with asthma. These results suggest that the greater odds of meeting the CR endpoint with FF/UMEC/VI 200/62.5/25 versus FF/VI 100/25 were mostly driven by the addition of UMEC. Although data over 52 weeks are needed to confirm achievement of CR, patients not yet considered for biologics with moderate-to-severe asthma uncontrolled on FF/VI 100/25 may gain greater benefits with simultaneous step-up to high-dose triple therapy versus increasing FF dose or adding UMEC alone."

Clinical • Retrospective data • Asthma • Immunology • Respiratory Diseases

Impact of Fluticasone Furoate/Umeclidinium/Vilanterol Inhaled Therapy on a Clinical Remission Endpoint in Asthma for Patients with Type 2 Inflammation: CAPTAIN Post Hoc Analysis (ATS 2025) - P3 | "Increasing FF dose and adding UMEC improved clinical outcomes for patients. More patients met the CR endpoint when adding UMEC, a long-acting muscarinic antagonist (LAMA), to FF/VI versus dual therapy alone, irrespective of T2 inflammation status at baseline in a symptomatic population not yet considered for biologics. Increasing FF dose also led to greater attainability of the CR endpoint, particularly in the patient subgroup with high T2 inflammation."

Clinical • Retrospective data • Asthma • Immunology • Inflammation • Respiratory Diseases

Establishing Outcomes of Once-daily Triple Therapy Plus as Needed Albuterol in Hospitalized Patients With COPD Exacerbations: The SUNDIAL-COPD Study (ATS 2025) - P4 | "Patients received Trelegy Ellipta 100/62.5/25 mcg as their primary inhaler within 24 hours of admission in combination with PRN albuterol...J Manag Care Spec Pharm, 2022. 28(12): p. 1366-1377."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Retrospective Analysis of Patient Profiles and Disease Burden for Patients With Chronic Obstructive Pulmonary Disease Who Initiated Triple Therapy in China (ATS 2025) - "Among patients in the SITT subgroup, 508 received FF/UMEC/VI and 3781 received BUD/GLY/FOR...CONCLUSIONS This study found that patients with COPD who were prescribed TT in China had a median age of 66 years and 64.8% were male. The most common comorbidities at baseline were hypertension and asthma, and more than half of patients with reported EOS had EOS >100 cells/μL."

Retrospective data • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison of Individual and Composite Measures to Assess Disease Stability over Time in Patients with COPD Treated with Fluticasone Furoate/Umeclidinium/Vilanterol: A Post Hoc Analysis (ATS 2025) - P3 | "Disease stability can be assessed using individual components or a combination. A greater proportion of patients receiving FF/UMEC/VI achieved disease stability versus dual therapies, across the individual component and composite definitions used, using either CAT score stability measurements. Disease stability can be considered for individual components or combining components into a two- or three-component composite."

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

Assessment of Disease Stability in Patients With COPD Receiving Single-inhaler Therapy With Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI and UMEC/VI: Post Hoc Analysis of the IMPACT Trial (ATS 2025) - P3 | "According to the definitions of disease stability used, a greater proportion of patients receiving FF/UMEC/VI achieved disease stability at Week 52, versus FF/VI or UMEC/VI. Patients receiving FF/UMEC/VI also maintained disease stability for longer, versus FF/VI or UMEC/VI. These findings provide further support for disease stability as a practical treatment target for patients with COPD, with further evidence needed to define optimum thresholds for each component."

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

A cost-effectiveness analysis comparing single-inhaler extrafine beclomethasone/formoterol/glycopyrronium bromide against other SITTs in adult patients with uncontrolled asthma in England. (PubMed, Health Econ Rev) - "BDP/FOR/GLY MS and HS were a dominant treatment alternative compared with FF/UMEC/VI, both MS and HS, and IND/GLY/MF HS in patients with asthma uncontrolled by ICS/LABA."

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

A Network Meta-Analysis of Triple Therapy Inhalers Used in Moderate to Severe Chronic Obstructive Pulmonary Disease (ISPOR 2025) - "The single-inhaler fluticasone furoate/umeclidinium/vilanterol and multi-inhaler budesonide/formoterol plus tiotropium had lower point estimates than other available triple therapy combinations, but these differences were not statistically significant... All nine triple therapy regimens included in this review provide similar clinical benefits in reducing the rates of moderate to severe exacerbations. In comparison to previous NMAs, the results of this NMA highlight that conclusions depend on the selection of studies (e.g., open-label vs. blinded), controlling the number of inhalers across treatment arms, and choice of statistical model (e.g., fixed vs random effects)."

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

Understanding How Formulary Pricing Models Shape Medication Accessibility and Financial Burden for Aging Populations (ISPOR 2025) - "Alzheimer’s treatments like galantamine and rivastigmine were often in higher tiers, raising out-of-pocket costs. COPD medications, including Symbicort and Trelegy Ellipta, despite preferred tier placement, posed financial challenges. Rheumatoid arthritis drugs, particularly Humira in Tier 5, imposed heavy costs. Similarly, ischemic heart disease and type 2 diabetes medications like Eliquis and Steglatro often appeared in higher tiers, worsening adherence issues... Older patients in the U.S., particularly those dealing with chronic illnesses, still encounter significant financial pressure due to increasing prescription prices. Although initiatives such as the Inflation Reduction Act provide some assistance, the strain persists, leading to low compliance and adverse health results. The results highlight the urgent necessity for strong policies to improve price transparency, increase access to affordable generics, and stop the unjust classification of generics in higher..."

Clinical • Pricing • Alzheimer's Disease • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Coronary Artery Disease • Diabetes • Heart Failure • Immunology • Inflammatory Arthritis • Metabolic Disorders • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Type 2 Diabetes Mellitus

Theravance Biopharma, Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "YUPELRI (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD): Achieved total US net sales of $58.3 million in Q1 2025, increasing 6% year-over-year (Q1 2025 vs Q1 2024)....TRELEGY Update: GSK posted first quarter 2025 global net sales of $854 million (up 14% from $749 million reported in the first quarter of 2024): FY 2025 global net sales of ~$3.41 billion (representing minus 1% growth vs. 2024) required to trigger $50M milestone from Royalty Pharma."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease

Analysis of adherence to ICS/LAMA/LABA in patients with asthma: a retrospective observational cohort study using medical claims data. (PubMed, Respir Investig) - "Patients with asthma in Japan who initiated FF/UMEC/VI SITT had significantly better treatment adherence than those who initiated MITT."

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

The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: Mahidol University | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Oct 2024

Enrollment open • Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (clinicaltrials.gov) - P4 | N=28 | Recruiting | Sponsor: Thammasat University | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Real-World Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol Initiation in Japanese Patients with Asthma Previously on Inhaled Corticosteroid/Long-Acting β2-Agonist Therapy: A Retrospective Cohort Study. (PubMed, J Clin Med) - "The proportion of patients with ≥1 SABA canister prescription dropped by 31% 0.69 [0.57, 0.84]; p < 0.001) in the JMDC database and 23% (0.77 [0.66, 0.90]; p < 0.001) in the MDV database. This suggests FF/UMEC/VI is effective in improving asthma exacerbations and reducing OCS and SABA use in Japanese patients previously using ICS/LABA in real-world clinical practice."

Journal • Real-world evidence • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Real-World Effectiveness of Single-Inhaler Triple Treatment Through Assorted Respiratory Outcomes When Switched From Multiple-Inhaler Triple Therapies (RESTART): A Prospective Cohort Study of Korean Patients With COPD. (PubMed, Int J Chron Obstruct Pulmon Dis) - "The Real-World Effectiveness of Single Inhaler Triple Treatment through Assorted Respiratory Outcomes when Switched from Multiple Inhaler Triple Therapies (RESTART) study aimed to evaluate the clinical benefits of switching from MITT to SITT using fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in a real-world Korean setting...The transition from MITT to SITT significantly improved COPD symptom management, pulmonary function, exacerbation rate, and treatment satisfaction in Korean cohort. Using a single inhaler to simplify therapy might increase patient compliance and improve clinical outcomes of COPD management."

Journal • Observational data • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases