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GlaxoSmithKline and Innoviva reported the U.S. Food and Drug Administration (FDA) has approved Trelegy Ellipta, the first once-daily, three-drugs-in-one inhaler for treatment of chronic obstructive pulmonary disease (COPD).
Trelegy Ellipta contains the antimuscarinic umeclidinium, the corticosteroid fluticasone furoate, and the long acting beta agonist vilanterol. The drugs provide bronchodilation and anti-inflammatory effects through three different mechanisms. The new inhaler will be available in the U.S. soon.
FDA approval was based partly on the FULFIL trial, demonstrating a 35% relative reduction in moderate/severe COPD exacerbations and improvement in airflow among patients taking Trelegy Ellipta, compared to those taking the inhaled corticosteroid-long acting beta-agonist combination inhaler budesonide-formoterol.
The European Medicines Agency, counterpart to the FDA, has also signaled it will likely approve Trelegy Ellipta.
Other 3-in-1 inhalers are likely coming soon. Chiesi Farmaceutici published results of the TRILOGY trial in Lancet in 2016, showing benefits of a triple inhaler containing beclomethasone dipropionate, formoterol fumerate and glycopyrronium bromide, compared to a inhaled corticosteroid-long acting beta agonist combination inhaler.
Assuming equivalence in tolerance/adverse effects and cost sharing by patients, three-in-one inhalers should improve adherence with COPD therapy, which could improve long-term symptom control and exacerbation frequency for people living with COPD.
GSK has not announced a price for Trelegy Ellipta. Insurers tend to impose greater cost sharing on patients for newer, more expensive drugs; on the other hand, triple inhalers will eliminate a drug copay for patients already using 2 inhalers to achieve triple-drug therapy for COPD.