Is this used for asthma?
Trelegy Ellipta is a once-daily therapy that combines three medicines into one inhaler. It combines an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA).
Trelegy Ellipta is not a fast-acting rescue medicine to be used during an asthma attack. It does not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine (for example, albuterol) for an attack. If you do not have a fast-acting rescue inhaler, contact your health care provider to have one prescribed for you.
In September 2017, the FDA approved Trelegy Ellipta for the long-term maintenance of chronic obstructive pulmonary disease (COPD). In April 2018, the indications were expanded to include the daily maintenance treatment of airflow obstruction in patients with COPD. In September 2020, the FDA approved a third indication for Trelegy for maintenance treatment of asthma in adults.
What are the 3 medications in Trelegy?
Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol) contains three medications in one inhaler for the treatment of adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for the treatment of asthma. Because it contains three medicines, it may be useful for those on a fixed-dose combination of fluticasone / vilanterol (Breo Ellipta) who need added bronchodilation, or those who are already using Breo Ellipta and Incruse Ellipta (umeclidinium).
Trelegy Ellipta contains:
Long-acting beta2-adrenergic agonist (LABA) medicines such as vilanterol are used with other medicines and are not used alone in asthma. When LABAs are used alone, it can increase the risk of hospitalizations and death from asthma problems. When an inhaled corticosteroid and a long-acting beta2-adrenergic agonist (LABA) are used together, there is not a significantly increased risk in hospitalizations and death from asthma problems.
Trelegy Ellipta should not be used in children. It is not known if Trelegy Ellipta is safe and effective in children.
Is Trelegy approved for asthma?
Yes, Trelegy is now approved to be used for asthma in adults. In October 2019, GSK and Innoviva submitted a supplemental new drug application (sNDA) to the FDA for approval of Trelegy Ellipta as a once-daily treatment for adults with asthma. Trelegy Ellipta is the first single inhaled, once-daily triple therapy available for both asthma and COPD in the U.S.
Phase III CAPTAIN Study for Ellipta
Approval for asthma was based on the Phase III CAPTAIN study that evaluated once-daily fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) in the treatment of patients with asthma. Trelegy Ellipta is now an option for patients who need more control than offered by standard dual therapy regimen with only inhaled corticosteroids and a long-acting beta2-adrenergic agonist (LABA).
In the CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study, a significant improvement in lung function was demonstrated with two different strengths of fluticasone furoate / umeclidinium / vilanterol: 100/62.5/25 mcg and 200/ 62.5/25 mcg. Over 2,400 adult patients were included.
The safety profile of Trelegy Ellipta in this study was consistent with the known profile of the individual components and their combinations.
The FDA-approved strength for treatment of both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone (not for COPD) which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.
Bottom Line
This is not all the information you need to know about Trelegy Ellipta for safe and effective use. Review the full Trelegy Ellipta information here, and discuss this information with your doctor or other health care provider.
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