The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.

Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.

The most common adverse events associated with Trelegy Ellipta include headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis, and the inhaler is contraindicated for people with “severe hypersensitivity to milk proteins.” Trelegy Ellipta is not indicated for people with asthma or acute bronchospasm.

“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.

The full press release is available on the GlaxoSmithKline website .

lfranki@frontlinemedcom.com

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