FDA approves Trelegy Ellipta (fluticasone furoate /umeclidinium/vilanterol ‘FF/UMEC/VI’) for treatment of asthma in adults

Approval was based on supplemental New Drug Application which included data from CAPTAIN study showing in patients uncontrolled on ICS/LABA, additional bronchodilation provided by Trelegy demonstrated significant improvements in lung function vs. FF/VI, in a single daily dose.

SPS commentary:

In UK, Trelegy Ellipta is currently only licensed as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.

In Feb 2020, the European Medicines Agency accepted a submission seeking approval for the treatment of asthma in adults.

Biospace Inc.

Resource links:

CAPTAIN study