A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK and Innoviva.
The application was submitted in July 2017, and the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the approval in January 2018.
GSK Senior VP and Head of Global Respiratory Franchise Jonathan Sweeting commented, “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.”
Innoviva Senior VP and Chief Scientific Officer Theodore J. Witek Jr. said, “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.”
Read the GSK/Innoviva press release.
