Regulatory Affairs

FDA expands GSK’s Trelegy Ellipta indication in COPD

Published 25 April 2018

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.

The new indication is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

It is not indicated for relief of acute bronchospasm or for the treatment of asthma.

GSK chief scientific officer and research and development president Hal Barron said: “Following the initial approval of Trelegy Ellipta in September, we have analysed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with chronic obstructive pulmonary disease.

“We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly. We will continue to analyse the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients.”

The approval is based on a supplemental New Drug Application (sNDA) supported by data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.

Innoviva senior vice president and chief scientific officer Ted Witek said: “Up to half of patients with COPD on maintenance therapy will have experienced at least one exacerbation in the past 12 months, so gaining an indication that reflects the role Trelegy Ellipta can play in reducing this risk is important.

“We welcome this regulatory update which will allow physicians to offer the benefits of once-daily single inhaler triple therapy to appropriate patients with COPD.”

Trelegy Ellipta was originally approved for use in the US in September 2017 for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo and require additional bronchodilation or who are receiving Breo and Incruse (UMEC).

A type II variation to support an expanded label in Europe was submitted to the European Medicines Agency (EMA) in February 2018 and is currently under review.

The boxed warning has also been removed from the Trelegy Ellipta prescribing information, in line with the recent updates to the ICS/LABA class.

Labelling changes to ICS/LABA combination medicines were implemented following a review of safety data submitted to the FDA by three companies including GSK and approved on December 20, 2017.

Source: Company Press Release.