FDA Expands COPD Drug Indication

The US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to include more patients with chronic obstructive pulmonary disease (COPD) than before.

Now, Trelegy Ellipta can be used for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations in patients with a history of exacerbations.
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However, the drug is not indicated for the relief of acute bronchoplasm or for the treatment of asthma.

The FDA approved the expanded indication of Trelegy Ellipta based on a supplemental New Drug Application submitted after the success of the InforMing the PAthway of COPD Treatment (IMPACT) study.

In the study, Trelegy Ellipta demonstrated superiority to Relvar/Breo Ellipta (FF/VI) and Anoro Ellipta (UMEC/VI) for various outcomes, such as reducing exacerbations and improving lung function and health related quality of life.

Trelegy Ellipta was first approved in the United States in September 2017 for the once-daily, maintenance treatment of COPD patients who were also receiving Breo and required additional bronchodilation, and for those who were also receiving both Breo and Incruse.

Due to recent updates to the inhaled corticosteroid/long-acting beta-agonist class, the boxed warning was removed from the prescribing information for Trelegy Ellipta, and labeling changes were implemented after a review of safety data was submitted to the FDA in December 2017.

—Christina Vogt

Reference:

Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD [press release]. London, UK, and Brisbane, AU. GlaxoSmithKline and Innoviva, Inc. April 24, 2018. https://www.businesswire.com/news/home/20180424006265/en/Once-Daily-Trelegy-Ellipta-Gains-Expanded-Indication-Treatment Accessed on April 25, 2018.