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Home Industry News GlaxoSmithKline’s Trelegy Ellipta recommended for EU approval in COPD

GlaxoSmithKline’s Trelegy Ellipta recommended for EU approval in COPD

15th September 2017

GlaxoSmithKline and Innoviva have announced that their new chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta has been recommended for EU approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of the fluticasone furoate/ umeclidinium/vilanterol triple therapy as a maintenance treatment in adult patients with moderate to severe COPD.

By combining an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist and a long-acting beta 2-adrenergic agonist (LABA), the new treatment is designed to offer benefits for those who have not been adequately treated with prior ICS/LABA therapy.

This is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP, with the decision based on the product's strong performance in prior clinical trials.

Patrick Vallance, GlaxoSmithKline's president of research and development, said: "We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers."

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