The European Commission has approved a label update to GlaxoSmithKline/Innoviva’s Relvar Ellipta, expanding the asthma therapy’s reach.
The regulator is allowing use of the once daily inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination in patients whose asthma is already adequately controlled on both of these medications.
The decision follows data from a non-inferiority lung function study showing that patients with adequately controlled asthma were able to switch to once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) from the twice-daily Seretide Accuhaler (fluticasone propionate/salmeterol), “without compromising their lung function,” the firm noted.
“The evidence supporting this regulatory update means doctors can be confident that patients taking once-daily Relvar Ellipta will experience comparable benefit in lung function and safety profile, as with a twice-daily ICS/LABA,” said Dr Theodore Witek Jr, Innoviva’s chief scientific officer.
Relvar Ellipta, which is sold Breo Ellipta in the US, was approved for the treatment of asthma and COPD in Europe in 2013.
In May last year, evidence from the ‘real-world’ Salford Lung Study showed that patients initiated with Relvar Ellipta had twice the odds of achieving an improvement in asthma control than those continuing with their usual care, which included ICS administered as monotherapy or as ICS/LABA combinations.