EMA Panel Backs Triple Therapy Inhaler Temybric Ellipta for COPD

Megan Brooks

April 26, 2019

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.

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