European Commission Expands Marketing Approval for GSK’s Relvar Ellipta

The inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination is now approved for more patients with asthma.

Nearly 360 million people worldwide suffer from asthma, a chronic lung disease in which the airways are inflamed and narrowed, leading to breathing difficulties. While there have been significant advances in the treatment of asthma, over half of patient still suffer from poor control of their symptoms, according to GlaxoSmithKline in a recent press release.

That press release announced the expansion of the marketing approval by the European Commission of its asthma drug Relvar Ellipta, which was co-developed with Innoviva. The drug (Breo Ellipta in the US) received EMA approval for the treatment of asthma and COPD in Europe in 2013.

Relvar Ellipta, which is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting β2-agonist, in the Ellipta® inhaler, can now be prescribed for patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist. 

The Type II variation regulatory approval was based on the results of a non-inferiority lung function study showing that patients whose asthma is adequately controlled using the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50 could switch to once-daily Relvar Ellipta without and change in lung function.


Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications