FDA Approves Trelegy Ellipta as First Single Inhaler Triple Therapy for Asthma

September 18th 2020
Jill Murphy, Assistant Editor
Jill Murphy, Assistant Editor

This is the first and only, once-daily single inhaler triple therapy approved for the treatment of both asthma and chronic obstructive pulmonary disease (COPD).

The FDA has approved fluticasone furoate, umeclidinium, and vilanterol (Trelegy Ellipta, GSK) for use in adults with asthma that remains uncontrolled despite treatment with their current maintenance therapy. This is the first and only, once-daily single inhaler triple therapy approved for the treatment of both asthma and chronic obstructive pulmonary disease (COPD), according to GSK.1

Andrew Thomas, vice president of Respiratory Business Unit at GSK, said this approval holds major significance for adults with uncontrolled asthma despite treatment with their current maintenance therapy. Due to the challenges that physicians may face to train their patients and prepare them for treatments, as well as the struggle for patients to remember how to take the treatment, this therapy will make a difference.

“There have been multiple inhaler triple therapies used in asthma previously, with a combination of at least 2 inhalers with different dosing regimens,” Thomas said in an interview with Contemporary Clinic. “With Trelegy Ellipta, it is only one inhalation a day in a triple therapy.”

The approval was based off the results of the CAPTAIN study conducted in adults 18 years of age and older whose asthma was inadequately controlled despite treatment with ICS/LABA maintenance asthma medication.2

The data showed that in patients with uncontrolled moderate or severe asthma on inhaled corticosteroid plus long-acting β 2-agonists, adding umeclidinium improved lung function but did not lead to a significant reduction in moderate and/or severe exacerbations. Further, these patients are recommended to use the single inhaler fluticasone furoate, umeclidinium, and vilanterol due to its favorable, high-risk benefit profile.2

Thomas mentioned that not only is this treatment more convenient, but it is 100 ml of improvement in lung function to help patients feel better, breathe easier, and live a fuller life with their asthma.

“We hope that with the addition of these new indications that more adult asthmatics in the United States can get control of asthma symptoms and live better lives because of this, and the same goes for COPD patients,” Thomas said in an interview with Contemporary Clinic. “Having this inhaler should make a big difference in the lives of those patients.”

REFERENCES

  • GSK’s Trelegy Ellipta the First Once-Daily, Single Inhaler Triple Therapy Approved for Asthma [email]. Accessed September 18, 2020.
  • Lee LA, Bailes Z, Barnes N, et al. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. The Lancet Respiratory Medicine. Doi:https://doi.org/10.1016/S2213-2600(20)30389-1.

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