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GSK Files Regulatory Submission in US for Once-Daily Closed Triple Combination Therapy FF/UMEC/VI for Patients with COPD
BRISBANE, Calif.--(BUSINESS WIRE)-- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing by GSK of a regulatory submission with the US Food and Drug Administration 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 closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK's Ellipta® dry powder inhaler.

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.

Dave Allen, Head of Respiratory R&D, said, "COPD is a progressive disease and its impact on patients can worsen over time. 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."

Mike Aguiar, CEO of Innoviva, Inc., added "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."

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. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.
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Source: press release, 11/21/16. http://investor.inva.com/releasedetail.cfm?ReleaseID=1000475

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GSK files regulatory submission in US for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD
21 November 2016
Issued: London

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing by GSK of a regulatory submission with the US Food and Drug Administration 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 closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta® dry powder inhaler.

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.

Dave Allen, Head of Respiratory R&D, said, “COPD is a progressive disease and its impact on patients can worsen over time. 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.”

Mike Aguiar, CEO of Innoviva, Inc., added “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.”

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. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.

*The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from: http://goldcopd.org. Accessed: November 2016
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Source: press release, 11/21/16. http://www.gsk.com/en-gb/media/press-releases/2016/gsk-files-regulatory-...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Umeclidinium / Vilanterol / Fluticasone furoate triple combinationRespiratoryAsthma and COPDMuscarinic antagonist / Long-acting beta-2 receptor agonist / CorticosteroidMuscarinic and Beta-2 receptors

Mechanism of action: Umeclidinium / Vilanterol / Fluticasone furoate triple combination brings together two bronchodilators the long acting muscarinic antagonist (Umeclidinium) and the long acting beta agonist (Vilanterol) with the corticosteroid Fluticasone furoate.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-11-21

Results: Pending