GSK and Innoviva have announced that an NDA for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW).
Trelegy Ellipta was approved in the US and in Europe for the treatment of COPD in 2017 and was approved in Canada earlier this year. The FDA recently approved GSK’s sNDA for an expanded indication for Trelegy.
GSK Head, Respiratory Therapy Area R&D, Dave Allen commented, “COPD is a debilitating lung disease affecting over five million people in Japan. Many patients require combination treatment with different types of medicines to reduce both symptoms and exacerbations but there is currently no triple therapy available in Japan delivered in a single inhaler. If approved, once-daily FF/UMEC/VI delivered in the Ellipta would be an important innovation in the management of COPD in Japan alongside our current range of treatments.”
Innoviva Senior VP and Chief Scientific Officer Ted Witek said, “We are delighted to have filed a new drug application for the first single inhaler triple therapy for the treatment of COPD in Japan where the prevalence of COPD is of public concern. We look forward to a decision from the MHLW, which, if positive, would provide a new therapeutic option for appropriate patients with COPD in Japan.”
Read the GSK and Innoviva press release.
