The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended two inhaled medications for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.
The medications are Elebrato Ellipta and Trelegy Ellipta, both from GlaxoSmithKline Trading Services.
Both contain the combination of fluticasone furoate (a corticosteroid), umeclidinium (a long-acting muscarinic receptor antagonist), and vilanterol (a selective long-acting, β2-adrenergic receptor agonist).
Elebrato Ellipta and Trelegy Ellipta will be available as predispensed 92-µg/55-µg/22-µg inhalational powder.
Both medications have been shown to improve lung function (as defined by change from baseline through FEV1 at week 24; coprimary endpoint) compared with budesonide 400 µg/formoterol 12 µg administered twice daily in patients with moderate to severe COPD that was not adequately controlled with a corticosteroid and a long-acting β-agonist, the EMA said.
The most common side effects are nasopharyngitis (7%), upper respiratory tract infection (2%), and headache (5%).
Further recommendations and details will be published in the European public assessment report after the European Commission grants full marketing authorization.
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Cite this: EMA Panel Backs Two New Inhalers for COPD - Medscape - Sep 15, 2017.
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