Arnuity Ellipta (fluticasone furoate) / GSK - LARVOL DELTA

Meds from…GSK now offered through TrumpRx DTC platform (Fierce Pharma) - "GSK... is offering DTC discounts on several of its Ellipta inhalers...through the platform....GSK’s Anoro Ellipta comes with a 49% DTC discount. Arnuity Ellipta is between 51-54% lower than its list price through the platform, while the cash price for Incruse Ellipta is 55% lower."

Commercial • Chronic Obstructive Pulmonary Disease

Correct use of inhalers for asthma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics (clinicaltrials.gov) - P2 | N=95 | Active, not recruiting | Sponsor: University of Virginia | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Jan 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2023

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

GSK announces cap of $35 per month on U.S. patient out-of-pocket costs for its entire portfolio of asthma and COPD inhalers (GSK Press Release) - GSK today announced it will cap out-of-pocket costs for eligible patients at no more than $35 per month for all of its asthma and chronic obstructive pulmonary disease (COPD) medicines...The out-of-pocket price cap will provide a significant benefit to patients taking these medicines whose monthly costs currently exceed $35....The program is wide reaching and will be implemented no later than January 1, 2025. The medicines in scope are: Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Advair HFA (fluticasone propionate and salmeterol inhalation aerosol). Anoro Ellipta (umeclidinium and vilanterol inhalation powder). Arnuity Ellipta (fluticasone furoate inhalation powder). Breo Ellipta (fluticasone furoate and vilanterol inhalation powder). Incruse Ellipta (umeclidinium inhalation powder). Serevent Diskus (salmeterol xinafoate inhalation powder). Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol...

Pricing • Asthma • Chronic Obstructive Pulmonary Disease

Study Finds No Benefit to Taking Fluticasone Furoate for COVID-19 Symptoms (Medical Dialogues) - "Fluticasone furoate was chosen for this study because inhaled corticosteroids had shown potential for treating COVID-19 in the outpatient setting....In addition to...members of the ACTIV-6 Executive Committee include...David Boulware..."

Novel Coronavirus Disease

Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics (clinicaltrials.gov) - P2 | N=95 | Recruiting | Sponsor: University of Virginia | Trial completion date: Jan 2022 ➔ Jan 2025 | Trial primary completion date: Dec 2020 ➔ Dec 2024

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

Monitoring Intermittent vs Regular inhaled corticoSteroids in asthma: MIRSA study (ANZCTR) - P4 | N=135 | Not yet recruiting | Sponsor: Dr John D Brannan

New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Benefits of triple therapy consistent regardless of age at asthma onset (Healio) - "Njira Lucia Lugogo, MD...presented a new post hoc analysis of the CAPTAIN study looking at the effects of age of asthma onset as a continuous variable on treatment outcomes at the CHEST Annual Meeting....'The CAPTAIN study showed that adding umeclidinium to fluticasone furoate and vilanterol...improved lung function and symptom control and led to numerical reductions in the annualized rate of moderate severe exacerbations in patients with uncontrolled asthma despite inhaled corticosteroid and LABA therapy,' Lugogo said during a presentation....Lugogo said it is important to note that greater uncertainty exists at the extremes of the age-of-onset range due to fewer patients at each end of the spectrum. 'Patients with asthma inadequately controlled on ICS/LABA would benefit from the addition of umeclidinium to fluticasone furoate/vilanterol triple therapy or from the use of a higher dose of fluticasone furoate irrespective of age of asthma onset,' Lugogo said."

Media quote • Asthma

Arnuity® Ellipta® Drug Use Investigation (clinicaltrials.gov) - P=N/A; N=336; Completed; Sponsor: GlaxoSmithKline; Recruiting ➔ Completed

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

GSK ’Relva Ellipta’ reports pneumonia in postmarketing investigation [Google translation] (docdocdoc.co.kr) - "The Ministry of Food and Drug Safety...has prepared an order (draft) to change the permission matters containing such contents and that related opinions will be submitted by the 12th of this month. According to the amendment, as a result of post-marketing surveys of 'Relva 100 Ellipta' and 'Relva 200 Ellipta'...the incidence rate of abnormal cases was 30.85% (992 people) regardless of causal relationship reached. Pneumonia and acute myocardial infarction were found in 4 patients, 0.12% of all patients, as serious adverse drug reactions that could not be excluded from causality....Following the marketing of the fluticasone furoate ingredient single drug 'Arnuity 100 Ellipta' and 'Arnuity 200 Ellipta', a proposal to change the approval was prepared...The incidence rate of abnormal cases irrelevant to the causal relationship...was 17.36% (113 persons), and pneumonia and bronchitis were reported as serious abnormal cases not related to the causal relationship."

Adverse events • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

"@FidelisCare plz explain why i get 90day @GSK #ArnuityEllipta but only 30day #AnoroEllipta even tho Rx written for 90days? and u #WontCover #TrellegyEllipta even tho it works better than the combo of anoro/arnuity imo... im reying on samples of trellegy from my dr!😡" (,@13ironz)