GlaxoSmithKline and Innoviva, Inc. announced that the European Commission has approved a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist.
The Type II variation regulatory approval has been supported by data from a non-inferiority lung function study, which demonstrated that patients with adequately controlled asthma were able to switch to the once-daily FF/VI 100/25, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50, without compromising their lung function. No new safety signals were identified and the adverse event data were consistent with the known safety profile for FF/VI established in patients with asthma.
Jonathan Sweeting, SVP and Head of Global Respiratory Franchise GSK, said: “Patients with asthma can continue to experience symptoms despite being adequately controlled and these symptoms can impact their lives. This label update gives doctors the option of switching appropriate patients from their current ICS/LABA to once-daily Relvar Ellipta.”
Dr. Theodore J. Witek Jr., Senior Vice President and Chief Scientific Officer of Innoviva, Inc., added: “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. We welcome this approval, which signifies an important milestone for Relvar Ellipta.”
The updated marketing authorisation by the European Commission will be reflected in the label for Relvar Ellipta for countries in the European Union.
Filed Under: Drug Discovery