GlaxoSmithKline (GSK) and Innoviva have filed a regulatory submission with the US Food and Drug Administration (FDA) for fluticasone furoate / umeclidinium / vilanterol (FF / UMEC / VI 100mcg / 62.5mcg / 25mcg) therapy for patients with chronic obstructive pulmonary disease (COPD).
The lung disease includes chronic bronchitis, emphysema or both and is characterised by obstruction to airflow that interferes with normal breathing.
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The latest submission follows the announcement made earlier this year to bring forward the timing of the US filing from the first half of 2018.
GlaxoSmithKline Respiratory R&D head Dave Allen said: “As reflected in the recently updated GOLD COPD Strategy, for those patients with advanced disease, multiple therapies such as ICS / LAMA / LABA combinations are often required and are typically delivered via two or more inhalers with potentially differing dose regimens.
“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.”
The once-daily, closed triple combination therapy consists of fluticasone furoate, umeclidinium, and vilanterol medicines delivered once-daily in GSK’s Ellipta dry powder inhaler.
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By GlobalDataComprising a new drug application for the maintenance treatment of patients with COPD, the submission is based on data from the closed triple combination therapy development programme.
Innoviva CEO Mike Aguiar said: “We are delighted that the US submission has been achieved some 18 months earlier than planned.
“If approved, FF / UMEC / VI as a once-daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”
The companies are planning a regulatory filing in the EU in the coming weeks.
