The new drug application submission to the US Food and Drugs Administration was made 18 months ahead of schedule.
The treatment for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema, is a once-a-day closed triple combination therapy, consisting of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI).
Dave Allen, head of Respiratory Research & Development at Glaxo, said multiple therapies in combination are often required for those patients with advanced forms of COPD.
“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,” Allen said.
Mike Aguiar, chief executive of Innoviva, said the company was delighted that the US submission had been achieved some 18 months earlier than expected.
A regulatory filing in the European Union is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.
Story by ProactiveInvestors