GSK Submits Application to EMA for New Asthma Indication of Single-Inhaler Triple Therapy Trelegy Ellipta (FF/UMEC/VI)
Feb 28, 2020 11:59
CST Updated
11:59
GSK
Pharmaceutical R&D Manufacturer
Innoviva
Small Molecule Drug Research, Development, and Production
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
FDA
U.S. Food and Drug Administration
News on February 28, 2020 /BioonBIOON/ --GlaxoSmithKline(GSK) and its partner Innoviva recently announced jointly that the European Medicines Agency (EMA) has accepted a regulatory submission seeking approval for a new indication of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI), a once-daily single-inhaler triple therapy, for the treatment of asthma in adults. In the United States, the application for this new indication of the drug for the treatment of asthma in adults is under review.FDAreview. Phase III CAPTAIN study data showed that in adult asthma patients whose condition remained inadequately controlled despite combination therapy with inhaled corticosteroids/long-acting β2-agonists (ICS/LABA),Compared with ICS/LABA and Relvar/Breo Ellipta (FF/VI)，Treatment with Trelegy Ellipta resulted in a statistically significant improvement in lung function.
Trelegy Ellipta is a once-daily, single-inhaler triple therapy (ICS/LAMA/LABA) administered via the Ellipta dry powder inhaler. This medication encompasses the three most widely used classes of inhaled drugs in current clinical practice, comprising: an inhaled corticosteroid (ICS), fluticasone furoate (FF); a long-acting muscarinic antagonist (LAMA), umeclidinium (UMEC); and a long-acting β2-agonist (LABA), vilanterol (VI).
In the United States and the European Union,Trelegy ElliptaIt has been approved for the treatment of chronic obstructive pulmonary disease (COPD). If the new indication for asthma is approved, the drugwill become the first once-daily single-inhaler triple therapy available for the treatment of asthma and COPD in the US and European markets.
Currently, there is no single-inhaler triple therapy available in Europe for the treatment of asthma. Asthma is a chronic lung disease that causes inflammation and narrowing of the airways, affecting 358 million people worldwide. Even with adherence to combination therapy with inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA), at least 30% of asthma patients remain symptomatic and require further treatment. Furthermore, the addition of extra bronchodilators administered via multiple inhalers has been shown to have beneficial effects on asthma symptoms and lung function. A single-inhaler triple therapy would benefit those who remain symptomatic despite receiving ICS/LABA combination therapy.AsthmaBrings a New Treatment Paradigm for Adult Patients.
Trelegy Ellipta was approved in the United States and the European Union in September and November 2017, respectively, for the treatment of patients with chronic obstructive pulmonary disease (COPD). It is the first single-inhaler triple therapy approved for COPD patients whose condition is not adequately controlled with dual bronchodilator therapy (ICS/LABA or LABA/LAMA). It is indicated as a once-daily maintenance treatment for airflow obstruction in patients with COPD (including chronic bronchitis and/or emphysema), including those inadequately controlled with FF/VI and those already receiving UMEC in combination with fixed-dose FF/VI. The drug is also indicated to reduce exacerbations in patients with a history of COPD exacerbations. Currently, the drug is not approved for the relief of acute bronchospasm or for the treatmentAsthma。
The new indication application for Trelegy Ellipta in the treatment of asthma is based on the results of the pivotal Phase III clinical study CAPTAIN (NCT02924688). This study involved 2,436 patients across 15 countries worldwide who were receiving maintenance therapy with ICS/LABA (>250 mcg/day fluticasone propionate or equivalent) but had insufficiently controlled conditions.AsthmaConducted in adult patients, the study evaluated the efficacy and safety of once-daily FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25, and 200/62.5/25 mcg) versus once-daily FF/VI (100/25 and 200/25 mcg).
The study results were announced this May, showing that the study met its primary endpoint: (1) Compared with Relvar/Breo (FF/VI) 100/25 mcg, FF/UMEC/VI 100/62.5/25 mcg significantly improved lung function (measured by the change from baseline in trough FEV1 at Week 24 of treatment) by 110 mL, with statistically significant data (p < 0.001, 95% CI: 66–153 mL); (2) Compared with Relvar/Breo (FF/VI) 200/25 mcg, FF/UMEC/VI 200/62.5/25 mcg significantly improved lung function by 92 mL, also with statistically significant data (p < 0.001, 95% CI: 49–135 mL). (Bioon.com)