LONDON (Alliance News) - GlaxoSmithKline PLC and Innoviva Inc said Tuesday they have filed a new drug application with the Japanese health ministry for lung disease treatment drug Trelegy Ellipta.
The companies have submitted regulatory application to the Japanese Ministry of Health, Labour & Welfare for once-daily fluticasone furoate/umeclidinium/vilanterol under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease.
"[Chronic obstructive pulmonary disease] 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," said Dave Allen, Glaxo's head of respiratory research & development division.
The application is based on data from the Phase III IMPACT study which included 378 patients from Japan. In the overall study population, fluticasone furoate/umeclidinium/vilanterol was superior to several other treatments on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
Trelegy Ellipta is currently licensed for use in the US, European Union and a number of other countries.
Shares in Glaxo were trading 0.5% lower at 1,493.20 pence each Tuesday morning.
Innoviva is a US-based healthcare-focused investment company.