The European Commission has approved GSK’s marketing authorization application for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD, the company said. The EMA Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the Trelegy Ellipta MAA in September 2017.
According to GSK, the company expects to launch Trelegy Ellipta in Europe before the end of 2017. In the US, Trelegy Ellipta was approved by the FDA in September 2017.
GSK Global Respiratory Franchise Senior VP and Head Eric Dube commented, “COPD is a serious lung disease that affects millions of people. Its progressive nature means symptoms can worsen over time with many patients also experiencing frequent debilitating exacerbations. A combination of different types of medicines can be required to achieve treatment goals. Trelegy Ellipta is the first medicine to be approved in Europe that delivers three effective molecules in a once-daily single inhalation. We believe this is an important innovation in COPD management and look forward to making it available for appropriate patients with COPD.”
Innoviva CEO Mike Aguiar said, “Knowing that appropriate COPD patients will require triple therapy, Trelegy Ellipta affords the convenience of administration of three classes of medicines in a single inhaler. Having all three major classes of combination medication (ICS/LABA, LAMA/LABA, and now single inhaler triple therapy) in the single Ellipta inhaler is an important advance in inhaled therapeutics.”
Read the GSK and Innoviva press release.
