FDA Approves Trelegy Ellipta for Asthma and COPD in US

The U.S. Food and Drug Administration (FDA) has approved GlaxoSmithKline plc's (GSK) Trelegy Ellipta for the treatment of asthma in adults. The medication, which combines three active ingredients in a single inhaler, is now approved for the maintenance treatment of both asthma and chronic obstructive pulmonary disease (COPD) in the United States.

This approval makes Trelegy Ellipta the first once-daily triple therapy in a single inhaler approved for both asthma and COPD. The drug can be used for asthma maintenance treatment in patients aged 18 and older who do not achieve adequate control with existing inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination therapies. The approved strength for asthma treatment is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25 micrograms.

GSK states that the new indication represents a significant advance for asthma patients who continue to experience symptoms despite managing multiple inhalers daily. The approval follows data from the CAPTAIN study, which demonstrated that Trelegy Ellipta significantly improved lung function in patients inadequately controlled on ICS/LABA therapy.

Trelegy Ellipta was initially approved in the U.S. for COPD in 2017. The company views this new approval as a reinforcement of its commitment to respiratory diseases. GSK has also received several other medicine approvals in 2020 across various therapeutic areas.