Triple therapy (fluticasone furoate+umeclidinium+vilanterol) filed with FDA for chronic obstructive pulmonary disease- GlaxoSmithKline and Innoviva
GlaxoSmithKline and Innoviva announced the filing of a regulatory submission with the US FDA for the once-daily, closed triple combination therapy (fluticasone furoate+umeclidinium+vilanterol) (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018.
The US regulatory submission of the closed triple therapy comprises a New Drug Application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. It is based on data from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination.
Comment: A regulatory filing in the EU is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017.
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