FDA Approves First Once-Daily Single Inhaler Triple Therapy for COPD

SEPTEMBER 19, 2017
Officials with the FDA have approved fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) (Trelegy Ellipta, GlaxoSmithKline and Innoviva), for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), according to a company press release. It is the first once-daily product approved in the United States that combines 3 active molecules in a single inhaler for the treatment of COPD.

The single inhaler triple therapy is intended for patients with COPD, including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction.

A combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist, Trelegy Ellipta should be delivered once-daily in GSK’s Ellipta dry powder inhaler. The approved strength is FF/UMEC/VI 100/62.5/25 mcg.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization for the medication as a maintenance treatment in appropriate adults with moderate-to-severe COPD. According to the press release, Trelegy Ellipta will be available in the United States soon.

The most common adverse reaction reported during trials of the medication include headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.

Trelegy Ellipta is not indicated to treat acute bronchospasm or asthma.

Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US [news release]. GSK’s website. . Accessed September 19, 2017.

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