Trelegy Ellipta Gains Expanded COPD Indication, Loses Boxed Warning
GlaxoSmithKline announced that the Food and Drug Administration (FDA) has expanded the indication for Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol) to include long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce COPD exacerbations in patients with a history of exacerbations.
The drug consists of fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered via an Ellipta dry powder inhaler.
Trelegy Ellipta was initially approved in September 2017 for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo Ellipta (fluticasone furoate, vilanterol) and require additional bronchodilation or who are receiving Breo Ellipta and Incruse Ellipta (umeclidinium).
The new FDA approval was based on data from the IMPACT (InforMing the PAthway of COPD Treatment) study that demonstrated superiority of Trelegy Ellipta vs Relvar/Breo Ellipta and Anoro Ellipta on various clinical endpoints, including reduction of exacerbations and improved lung function and health-related quality of life.
In addition, the Boxed Warning regarding an increased risk of asthma-related death has been removed from the Trelegy Ellipta prescribing information as reflected across the ICS/LABA drug class.
Trelegy Ellipta is available as 100mcg/62.5mcg/25mcg strength inhalation powder in 2 foil strips, each with 30 blisters (30 inhalations).
For more information call (888) 825-5249 or visit TrelegyEllipta.com.