Trelegy Ellipta Gets EMA Advisory Support Week Before FDA Decision


The single-dose inhaler was the first of its kind to get positive recommendation from EMA's Committee for Medicinal Products for Human Use.

EMA, Trelegy Ellipta, COPD

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given vocal support for the approval of fluticasone furoate/umecldinium/vilanterol (Trelegy Ellipta) for particular maintenance of moderate-to-severe chronic obstructive pulmonary disease (COPD).

The CHMP endorsement for Trelegy Ellipta was for the combination inhalation therapy’s treatment of COPD in adult patients who are not properly treated by inhaled corticosteroid and a long-acting beta 2 agonist.

Created by GlaxoSmithKline (GSK) and Innoviva, Trelegy Ellipta is a combination of inhaled corticosteroid fluticasone, long-acting muscarinic antagonist Incruse Ellipta (umeclidinium), and long-acting beta 2 adrenergic agonist vilaenterol.

The treatment is delivered to patients once daily via GSK’s Ellipta dry powder inhaler — making Trelegy Ellipta the first once-daily single inhaler therapy to be given recommendation by the CHMP, according to the companies.

Trelegy Ellipta’s filing included positive results from a phase 3 FULFIL study that investigated the treatment’s ability versus twice-daily budesonide/formoterol (SYMBICORT Turbohaler).

SYMBICORT made domestic progression in COPD treatment this week. The AstraZeneca pressurized metered dose inhaler was approved by the US Food and Drug Administration (FDA) for a label update to include treating exacerbations in COPD adult patients.

Patrick Vallance, president of R&D for GSK, said the unique characteristics of Trelegy Ellipta would make it a beneficial addition to the market.

“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,” Vallance said.

While awaiting EMA decision, the triple therapy treatment is also under consideration by US, Australia and Canada regulation entities. The FDA decision date for the treatment is September 21.

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