FDA Approves First 3-in-1 Inhaler for COPD

The US Food and Drug Administration has approved once-daily Trelegy Ellipta as maintenance therapy for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, who are receiving fixed-dose furoate and vilanterol for airflow obstruction and to reduce exacerbations, or receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

Trelegy Ellipta is the first FDA approved once-daily single dose inhaler that combines furoate, a corticosteroid, umeclidinium, a long-acting muscarinic antagonist, and vilantero, a long-acting beta2-adrenergic agonist. The dry powder inhaler is approved to dispense furoate at 100 mcg, umeclidinium at 62.5 mcg, and vilanterol at 25 mcg.
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Common adverse reactions reported with Trelegy Ellipta included headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.

In addition, Trelegy Ellipta has been found to increase the risk of pneumonia in patients with COPD, and increase the risk of asthma-related death in patients with asthma.

Trelegy Ellipta is not indicated for the treatment of asthma or acute bronchospasm.

—Melissa Weiss

Reference:

Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US [press release]. London, UK: GlaxoSmithKline plc, September 18, 2017. https://www.gsk.com/en-gb/media/press-releases/trelegy-ellipta-approved-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-appropriate-patients-with-copd-in-the-us/. Accessed September 19, 2017.