FDA Approves Fluticasone Furoate, Umeclidinium, Vilanterol for Treatment of Asthma

The FDA has approved the triple therapy of fluticasone furoate, umeclidinium, and vilanterol (Trelegy Ellipta, GSK) for the treatment of asthma in patients aged 18 years and older. The drug was previously approved for use in patients with chronic obstructive pulmonary disease (COPD).

The triple combination therapy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the United States, according to the press release.

The approval was based on data from the CAPTAIN study, which showed significant improvements in lung function with the use of fluticasone furoate, umeclidinium, and vilanterol compared with using only fluticasone furoate and vilanterol in a single daily dose and an easy-to-use inhaler.

The most common adverse reactions after administration of fluticasone furoate, umeclidinium, and vilanterol include hypersensitivity reactions, such as anaphylaxis, angioedema, rash, and urticaria. Further, there is an increased risk of pneumonia, as well as a worsening of infections, such as fungal and bacterial infections, for patients who take corticosteroids such as fluticasone furoate, umeclidinium, and vilanterol.

REFERENCE

FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US. GSK. https://www.gsk.com/en-gb/media/press-releases/fda-approves-trelegy-ellipta-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-both-asthma-and-copd-in-the-us/. Published September 9, 2020. Accessed September 14, 2020.