GSK files regulatory submission with US FDA for FF / UMEC / VI therapy

21 November 2016 (Last Updated November 21st, 2016 18:30)

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).

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.

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.

"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."

“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.

Comprising 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.