The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended Temybric Ellipta (GlaxoSmithKline) for the maintenance treatment of adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Temybric Ellipta contains the combination of fluticasone furoate (a corticosteroid), umeclidinium (a long-acting muscarinic receptor antagonist), and vilanterol (a selective long-acting β2-adrenergic receptor agonist). It will be available as a predispensed 92-µg/55-µg/22-µg inhalational powder.
Temybric Ellipta has been shown to improve lung function, as defined by change from baseline trough FEV1 at week 24. The most common side effects are nasopharyngitis (7%), upper respiratory tract infection (2%), and headache (5%).
Temybric Ellipta is indicated as a maintenance treatment in adults with moderate-to-severe chronic COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.
The application for Temybric Ellipta was an informed consent application, which makes use of data from the dossier of a previously authorized medicine.
Further recommendations and details will be published in the European public assessment report after the European Commission grants full marketing authorization.
Cite this: EMA Panel Backs Triple Therapy Inhaler Temybric Ellipta for COPD - Medscape - Apr 26, 2019.