September 9, 2020

The U.S. FDA has approved a new indication for Trelegy® Ellipta™ (fluticasone furoate/umeclidinium/vilanterol) oral inhalation powder, manufactured by GlaxoSmithKline. The product is now indicated as a maintenance treatment for asthma in patients who are at least 18 years of age. Trelegy Ellipta delivers a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta agonist (LABA).

Asthma is a chronic respiratory condition that causes inflammation and narrowing of the airways. It is often treated with inhaled corticosteroids (to reduce inflammation) and bronchodilators. There are two main types of inhaled bronchodilators used in asthma treatment, LABAs and LAMAs, each of which work differently to help open constricted airways and ease a patient’s breathing.

In a clinical study, patients whose asthma was not adequately controlled on ICS/LABA therapy experienced significant improvement in lung function with the additional LAMA therapy provided by Trelegy Ellipta. Recommended dosing under the new indication is one actuation of Trelegy Ellipta once daily, taken via oral inhalation.

First FDA approved in 2017, the product is also indicated to provide maintenance treatment for chronic obstructive pulmonary disease (COPD).

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