Yupelri (revefenacin) / Theravance Biopharma, Viatris - LARVOL DELTA

Theravance Biopharma to Present New Analyses Highlighting YUPELRI (revefenacin) Outcomes in COPD at the 2025 CHEST Annual Meeting (PRNewswire) - "A retrospective cohort study of claims data demonstrated that following hospital discharge, patients adherent to YUPELRI experienced significantly fewer, and less severe, exacerbations and had significantly lower healthcare costs than non-adherent patients....Post-hoc analyses of a Phase 3 safety study showed that patients taking YUPELRI had significantly lower incidence of moderate-to-severe acute exacerbations, and overall, less severe exacerbations, than patients taking tiotropium."

P3 data • Retrospective data • Chronic Obstructive Pulmonary Disease

ADHERENCE TO REVEFENACIN ASSOCIATED WITH REDUCTIONS IN EXACERBATIONS AND HEALTH CARE COSTS FOLLOWING A COPD-RELATED HOSPITALIZATION (CHEST 2025) - "Moderate exacerbations were defined as an outpatient COPD visit accompanied by a filled prescription for a course of theophylline, aminophylline, or an oral corticosteroid or oral antibiotic within 7 days of the outpatient visit. Patients with COPD who were hospitalized, prescribed nebulized revefenacin post-discharge, and adhered to their medication demonstrated statistically significant reductions in both exacerbations and healthcare costs compared to patients who did not adhere to prescribed revefenacin. CLINICAL IMPLICATIONS: Results demonstrate that revefenacin can be effective in reducing COPD exacerbations and the associated costs, though adherence to medication remains critical."

Adherence • Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • Squamous Cell Carcinoma

EXACERBATION RATES IN COPD PATIENTS: A RETROSPECTIVE ANALYSIS OF THE NEBULIZED ONCE DAILY LONG-ACTING MUSCARINIC ANTAGONIST REVEFENACIN IN A 52-WEEK SAFETY STUDY (CHEST 2025) - " This retrospective data analysis evaluated exacerbation rates in a 52-week, randomized, open-label Phase 3 safety trial comparing revefenacin (175 and 88 mcg) with tiotropium HandiHaler® in patients with moderate-to-severe COPD. In this retrospective analysis, exacerbations over 52 weeks are reported for COPD patients treated with revefenacin or tiotropium. These findings suggest that once-daily revefenacin provides a viable long-term exacerbation control, offering an alternative nebulized LAMA option for COPD patients. CLINICAL IMPLICATIONS: Once-daily revefenacin provides a long term exacerbation profile at least as effective as tiotropium based upon this retrospective analysis over 52 weeks."

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

Comparison of nebulized long-acting muscarinic antagonist (LAMA) revefenacin to short acting muscarinic antagonist (SAMA) ipratropium in COPD patients with acute respiratory failure requiring mechanical ventilation (ERS 2025) - "Nebulized revefenacin once daily in mechanically ventilated COPD patients in ARF is a feasible alternative to SAMA and reduces resource utilization for bronchodilator delivery. Ventilatory mechanics show potentially greater benefit of revefenacin than ipratropium on airway resistance."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Stepwise Management of Status Asthmaticus Refractory to Initial Therapy: A Case Report. (PubMed, Cureus) - "First, the patient was treated with inhaled beta-2 agonist (albuterol) and corticosteroids (prednisone, dexamethasone, and methylprednisolone). The patient did not improve with these treatments and was given the anticholinergic agent ipratropium bromide in an attempt to increase bronchodilation. Nebulized racemic epinephrine was then added to the patient to optimize maximum bronchodilation and vasoconstriction in an attempt to reduce airway edema and inflammation. To reduce ventilator peak airway pressures through sedation and paralytics, rocuronium and cisatracurium (Nimbex) were administered. Ketamine was added as a sedative and bronchodilator. Propofol and midazolam (Versed) were used to sedate the patient for mechanical ventilation. After the acute episode, maintenance therapy included inhaled corticosteroids (budesonide), a long-acting beta-2 agonist (arformoterol), a long-acting muscarinic antagonist (revefenacin), and montelukast (a leukotriene receptor..."

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

RARICO: Revefenacin in Acute Respiratory Insufficiency in COPD (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: University of California, Los Angeles | Recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Jan 2025 | Trial primary completion date: Apr 2025 ➔ Jan 2025

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

Theravance Biopharma, Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "Achieved total U.S. net sales of $66.3 million in Q2 2025, increasing 22% year-over-year (Q2 2025 vs Q2 2024)....Net sales benefited from continued improvement to net pricing and a one-time favorable adjustment to net price....Earned $7.5 million milestone payment from Viatris in Q2 2025 for YUPELRI approval in China."

Commercial • Chronic Obstructive Pulmonary Disease

Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators (clinicaltrials.gov) - P4 | N=72 | Recruiting | Sponsor: University of Tennessee Graduate School of Medicine

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

Quantification and Aerodynamic Particle Size Distribution of Revefenacin Aerosol With UHPLC-MS/MS. (PubMed, J Sep Sci) - "These findings indicate that the aerodynamic properties of revefenacin aerosol remain stable over prolonged nebulization. This study establishes a reliable analytical method for revefenacin aerosol quantification and provides valuable insights into its aerodynamic characteristics, supporting its further application in chronic obstructive pulmonary disease treatment."

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

Theravance Biopharma Announces Approval of YUPELRI (revefenacin) by China’s NMPA Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.) (PRNewswire) - "Theravance Biopharma, Inc....announced that Viatris Inc. ('Viatris'), has secured regulatory approval from China's National Medical Products Administration (NMPA) for YUPELRI (revefenacin) inhalation solution, the first once–daily nebulized long–acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China...This approval triggers a one-time $7.5 million milestone from Viatris to Theravance Biopharma, which is expected to be received in Q3 2025. Theravance Biopharma is also eligible for further sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China. Viatris is responsible for all aspects of development and commercialization of YUPELRI in China."

China approval • Chronic Obstructive Pulmonary Disease

Differences in Demographic and Clinical Profiles Among Patients Adherent Vs. Non-Adherent to Revefenacin Following a COPD-Related Hospitalization (ISPOR 2025) - "Demographic and clinical differences were observed between patients adherent vs. non-adherent to revefenacin post COPD hospitalization. This is the first real world study observing adherence on revefenacin prescribed after a recent COPD hospitalization, and highlights potential age, racial and socioeconomic disparities that present opportunities to improve medication adherence."

Clinical • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Diabetes • Heart Failure • Immunology • Metabolic Disorders • Mood Disorders • Psychiatry • Respiratory Diseases

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

Development of a novel stability-indicating UHPLC method for revefenacin quality control and impurity identification using 2D-LC-HRMS. (PubMed, J Pharm Biomed Anal) - "The results demonstrate that this method is suitable for Rev quality control. The novel stability-indicating UHPLC method developed for quantifying Rev DPs offers a reliable approach for quality assurance."

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

Nebulized Long-Acting Bronchodilators to Treat Acute Respiratory Failure in an Older Adult: A Case Report. (PubMed, Cureus) - "This report describes the case of a 79-year-old man admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19) and treated with long-acting nebulized bronchodilators, arformoterol and revefenacin. In this case, both medications were used for their rapid-onset and long-duration bronchodilator activity to treat acute respiratory failure secondary to COVID-19. This older adult clinically improved within three days of nebulized long-acting bronchodilator use."

Journal • Acute Respiratory Distress Syndrome • Chronic Obstructive Pulmonary Disease • Critical care • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

RARICO: Revefenacin in Acute Respiratory Insufficiency in COPD (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: University of California, Los Angeles | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Apr 2025

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

[Longmen Family] Changfeng Pharmaceutical’s inhaled revefenacin solution for the treatment of COPD has been approved for clinical use [Google translation] (bydrug.pharmcube.com) - "Recently, Changfeng Pharmaceutical Co., Ltd. has obtained the clinical implicit approval of the National Medical Products Administration (NMPA) for its independently developed new product, revefenacin solution for inhalation. As a long-acting muscarinic antagonist (LAMA), revefenacin only needs, which can provide treatment for patients and greatly improve their convenience."

New trial • Chronic Obstructive Pulmonary Disease

Theravance Biopharma, Inc. Reports Third Quarter 2024 Financial Results and Announces Initiatives to Unlock Shareholder Value (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): Realized total net sales of $62.2 million for the quarter, representing 7% growth compared with Q3 2023 and 14% sequential growth compared with Q2 2024. Demand up 14%, (Q3 2024 vs Q3 2023) exceeding expectations and year-to-date trends....TRELEGY Update: GSK posted third quarter 2024 global net sales of approximately $789 million (up 17% from $675 million reported in the third quarter of 2023), bringing year-to-date TRELEGY global net sales to approximately $2.6 billion (up 30% from the same period in 2023)."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease

Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD. (PubMed, Int J Chron Obstruct Pulmon Dis) - P3 | "This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. Assessing additional complementary COPD clinical trial endpoints can help clinicians make treatment decisions."

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

Theravance Announces Publication of YUPELRI (revefenacin) Area Under the Curve Spirometry Analysis in the International Journal of Chronic Obstructive Pulmonary Disease (PRNewswire) - "Theravance Biopharma....today announced the publication of a sub-study of the pivotal 12-week, randomized, registrational revefenacin Phase 3 trials (Trials 0126 [NCT02459080] and 0127 [NCT02512510]) for YUPELRI...evaluating the area under the curve (AUC) lung function effects in moderate-to-very-severe chronic obstructive pulmonary disease (COPD) patients....Analysis of a retrospective, pooled sub-study from Phase 3 Studies 0126 and 0127 demonstrated that revefenacin (n = 50) improved bronchodilation versus placebo (n = 47) in patients with moderate-to-very-severe COPD when assessed by FEV1 AUC....Day 84 bronchodilation improvements were sustained over 24 hours vs. placebo, with mean differences of 282 mL, 220 mL, 205 mL and 212 mL for FEV1 AUC0–2h, AUC0–12h, AUC12–24h and AUC0–24h, respectively, (p<0.001 for all)."

Retrospective data • Chronic Obstructive Pulmonary Disease

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

Theravance Biopharma, Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update (PRNewswire) - "YUPELRI (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long- acting muscarinic agent) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD): Realized total net sales of $54.5 million for the quarter, a decrease of 1% compared with the same period in 2023....Granted an additional method of use patent for YUPELRI on July 30, 2024, with an expiration date of August 2039. Listed in the FDA Orange Book....TRELEGY: GSK posted second quarter 2024 global net sales of approximately $1.1 billion (up 40% from $760 million reported in the second quarter of 2023), bringing year-to-date TRELEGY global net sales to approximately $1.8 billion (up 37% from the same period in 2023)."

Patent • Sales • Chronic Obstructive Pulmonary Disease

Molecular docking aided machine learning for the identification of potential VEGFR inhibitors against renal cell carcinoma. (PubMed, Med Oncol) - "The identified compounds such as Pazopanib, Atogepant, Drosperinone, Revefenacin and Zanubrutinib shown the binding energy - 7.0 to - 9.5 kcal/mol against VEGF receptor in the molecular docking studies and have been observed as stable in the molecular dynamic simulations performed for the period of 500 ns. Harnessing the machine learning approaches revealed that clustering with K = 10 exhibits the relevance through high binding energy and satisfactory logP values, setting them apart from compounds in distinct clusters. Therefore, the identified compounds are found to be potential to inhibit the VEGFR-2 and the present study will be a benchmark to validate the compounds experimentally."

Journal • Machine learning • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Estimating Tiotropium Wasted Doses After Adding Revefenacin to an Inpatient Formulary: A Single-Center Cross-Sectional Study. (PubMed, Hosp Pharm) - " Multidose inhalers of tiotropium dispensed to hospitalized patients contributed to wasted doses compared to nebulized single-use revefenacin vials. Opportunities exist to minimize wasted doses of multidose long-acting inhalers dispensed to hospitalized patients."

Journal • Observational data

Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update (PRNewswire) - "YUPELRI (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long- acting muscarinic agent) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD): Achieved total net sales of $55.2 million for the quarter, increasing 18% year-over-year (Q1 2024 vs Q1 2023)....GSK posted first quarter 2024 global net sales of $749 million (up 32% from $567 million reported in the first quarter of 2023). As of January 1, 2024....The next milestone payment of $25 million will be achieved if TRELEGY global net sales are approximately $2.9 billion in 2024 (an increase of 5% compared with 2023). A second milestone payment of another $25 million (for a total of $50 million) can be achieved if TRELEGY global net sales exceed approximately $3.2 billion in 2024 (an increase of 17% compared with 2023)."

Commercial • Sales • Chronic Obstructive Pulmonary Disease