GlaxoSmithKline plc (LON:GSK, NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) have made a new drug application in Japan for a jointly-developed treatment of chronic obstructive pulmonary disease (COPD).
The submission has been made to the Japanese Ministry of Health, Labour and Welfare for a once-a-day inhaled treatment that will be marketed under the name Trelegy Ellipta.
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It is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.
The new drug application is primarily based on data from the Phase III IMPACT study that included 378 patients from Japan.
"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 [fluticasone furoate/umeclidinium/vilanterol] delivered in the Ellipta would be an important innovation in the management of COPD in Japan alongside our current range of treatments,” said Dave Allen, the head of the respiratory therapy area research & development at Glaxo.
FF/UMEC/VI is currently licensed for use in the US, EU and a number of other countries under the brand name Trelegy Ellipta. It contains three molecules delivered in the Ellipta dry powder inhaler that is used across Glaxo's new portfolio of inhaled COPD medicines.