GlaxoSmithKline has submitted an NDA in the US for its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) dry powder inhaler for the treatment of COPD, according to an announcement from GSK and Innoviva. The product will be delivered by GSK’s Ellipta device.
Earlier this year, GSK announced that it would file the submission by the end of 2016 instead of waiting until 2018. At the time, the company said that it also planned to file a marketing application in Europe by the end of 2016; it now says that a European regulatory submission is expected within a few weeks.
GSK Head of Respiratory R&D Dave Allen commented, “COPD is a progressive disease and its impact on patients can worsen over time. As reflected in the recently updated GOLD COPD Strategy, for those patients with advanced disease, multiple therapies such as ICS/LAMA/LABA combinations are often required and are typically delivered via two or more inhalers with potentially differing dose regimens. This first regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies.”
Innoviva CEO Mike Aguiar said, “We are delighted that the US submission has been achieved some 18 months earlier than planned. If approved, FF/UMEC/VI as a once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”
Read the GSK and Innoviva press release.
