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

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

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

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

Post Hoc Analysis of Lung Function Improvement and Patient-Reported Outcomes with Revefenacin in Adults with Moderate-to-Very Severe COPD and Comorbid Anxiety or Depression. (PubMed, Chronic Obstr Pulm Dis) - "Revefenacin was well tolerated regardless of A/D status, with a minimal incidence of treatment-emergent antimuscarinic adverse events across subgroups. In this analysis, revefenacin versus placebo significantly improved health outcomes in patients with moderate-to-very severe COPD with A, +A/+D, and -A/-D, but not in patients with D. The safety profile of revefenacin was not affected by comorbid anxiety/depression status."

Journal • Patient reported outcomes • Retrospective data • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Immunology • Mood Disorders • Psychiatry • Pulmonary Disease • Respiratory Diseases

Theravance Biopharma Announces Results from the Phase 4 YUPELRI PIFR-2 Study in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (PRNewswire) - P4 | N=404 | PIFR-2 (NCT05165485) | Sponsor: Theravance Biopharma | "Theravance Biopharma....today announced results from the Phase 4 PIFR-2 study of YUPELRI^® (revefenacin) inhalation solution, the only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for maintenance treatment of COPD....The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV1) at Day 85....YUPELRI demonstrated safety and tolerability consistent with its profile in previous clinical studies."

P4 data • Chronic Obstructive Pulmonary Disease

PIFR-2: Phase 4 COPD and Suboptimal Inspiratory Flow Rate (clinicaltrials.gov) - P4 | N=404 | Completed | Sponsor: Theravance Biopharma | Recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Nov 2023 | Trial primary completion date: Sep 2022 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • 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 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

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

Revefenacin administered to an older adult in the intensive care unit: a case report (ASHP 2023) - No abstract available

Clinical • Critical care

Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI (revefenacin) Phase III Trial in China for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) (PRNewswire) - P3 | N=258 | NCT05046795 | Sponsor: Jiangsu HengRui Medicine Co., Ltd | "Viatris Inc....today announced positive results from the YUPELRI^® (revefenacin) Phase III placebo-controlled clinical trial conducted in China assessing the efficacy and safety of YUPELRI....Top-line results showed that YUPELRI met its primary efficacy endpoint demonstrating a statistically significant increase in trough FEV1 (forced expiratory volume in one second) versus placebo. The results are comparable to those from studies of the same design used for U.S. registration and provide support for a regulatory filing in China anticipated to occur in mid-2024....Primary efficacy analysis of change from baseline in trough FEV1 measured 24 hours after the final dose at week 12 detected a mean (95% confidence intervals) treatment difference of 150.9 (104.1, 197.7) mL compared to placebo."

Non-US regulatory • P3 data: top line • Chronic Obstructive Pulmonary Disease

Evaluation of a New Formulary Medication Via Vibrating Mesh Nebulizer (AARC 2023) - "The medications used were NACL 0.9% BID, Budesonide .5mg BID, Arformoterol Tartrate 15 µg BID, and Revefenacin 175 µg QDAY. Visual inspection, temperature, and time were adequate throughout the study. Therefore, we believe Revefenacin can be adequately delivered through the vibrating mesh nebulizer. View this table:View inlineView popupTable 1."

Chronic Obstructive Pulmonary Disease

Theravance Biopharma, Inc. Reports Third Quarter 2023 Financial Results and Provides Business Update (PRNewswire) - "YUPELRI...Achieved total net sales of $58.3 million for the quarter, increasing 9% year-over-year (Q3 2023 vs Q3 2022) and 6% quarter-over-quarter (Q3 2023 vs Q2 2023). Sales growth was driven by increasing customer demand, up 14% year-over-year....TRELEGY ELLIPTA...GSK posted third quarter 2023 global net sales of $675 million (up 22% from $552 million reported in the third quarter of 2022). Year to date, through the third quarter, GSK has posted TRELEGY global net sales of $2.0 billion. Theravance Biopharma is entitled to a milestone payment from Royalty Pharma of $50 million if TRELEGY global net sales are equal to or exceed $2.9 billion7 in 2023, the first of $250 million of potential milestones that can be achieved between 2023 and 2026....Total revenue for the third quarter of 2023 was $15.7 million, consisting almost entirely of Viatris collaboration revenue."

Commercial • Sales • Asthma • Chronic Obstructive Pulmonary Disease

FEASIBILITY, SAFETY, AND EFFICACY OF NEBULIZED LONG-ACTING BRONCHODILATORS VS NEBULIZED SHORT-ACTING BRONCHODILATORS IN HOSPITALIZED PATIENTS WITH EXACERBATIONS OF COPD (CHEST 2023) - "In non-ventilated, hospitalized patients with ECOPD, nebulized formoterol and revefenacin had comparable efficacy and safety to nebulized albuterol and ipratropium. A long-acting regimen reduced the number of bronchodilator doses administered during the hospital stay. CLINICAL IMPLICATIONS: In hospitalized patients with ECOPD, a long-acting regimen of nebulized formoterol and revefenacin could be substituted for a standard-of-care regimen of short-acting nebulized albuterol and ipratropium with comparable efficacy and safety."

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

Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD) (clinicaltrials.gov) - P3 | N=258 | Completed | Sponsor: Mylan Pharma UK Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Jul 2023 | Trial primary completion date: Oct 2023 ➔ Jul 2023

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

Theravance Biopharma, Inc. Reports Second Quarter 2023 Financial Results and Provides Business Update (PRNewswire) - "YUPELRI achieved $55.0 million Q2 2023 sales, increasing 12% year-over-year (Q2 2023 vs Q2 2022). YUPELRI's share of the long-acting nebulized COPD market again reached all-time highs, with hospital share at 15.2% (vs. 11.6% in Q2 '22) and community share at 29.0% (vs. 25.3% in Q2 '22)....TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD and asthma) GSK posted second quarter 2023 global net sales of $760 million (up 29% from $591 million reported in the second quarter of 2022).5 Year to date, through the second quarter, GSK has posted TRELEGY global net sales of $1.3 billion. Theravance Biopharma is entitled to a milestone payment from Royalty Pharma of $50 million if TRELEGY global net sales are equal to or exceed $2.9 billion6 in 2023, the first of $250 million of potential milestones that can be achieved between 2023 and 2026."

Commercial • Sales • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases