According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that is adequately controlled with an inhaled corticosteroid and a LABA. The companies said that they expect to get the final decision by the end of the first quarter of 2018.
GSK announced submission of an application to extend use of Relvar Ellipta for this indication in July 2017. Relvar Ellipta has been approved in Europe for the treatment of asthma not adequately controlled by ICS/LABA therapy since 2013.
GSK Senior VP and Global Head of Respiratory Franchise Jonathan Sweeting commented, “There are many asthma patients in Europe who, despite being adequately controlled on a twice-daily ICS/LABA, are still experiencing symptoms or problems with their asthma. We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients.”
Innoviva CEO Mike Aguiar said, “Asthma is a persistent condition; management guidelines recommend treatment be individualized until control has been achieved. Today’s positive opinion supports once-daily Relvar Ellipta as an important option for doctors and patients in effectively managing asthma.”
Read the GSK and Innoviva press release.
