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GlaxoSmithKline plans to file NDA in U.S. for FF/UMEC/VI in patients with COPD

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GlaxoSmithKline plc and Innoviva, Inc announced that, following discussions with the US FDA ,GSK has brought forward the plan to file a NDA in the US for the once-daily closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; a combination inhaled corticosteroid, long-acting muscarinic antagonist, long-acting beta agonist) for patients with chronic obstructive pulmonary disease (COPD). The US regulatory submission is now anticipated by the end of 2016, rather than the first half of 2018, as previously expected.

The NDA for the closed triple combination therapy will comprise data now in hand from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination.The companies continue to expect an EU regulatory submission of the closed triple combination therapy for COPD by the end of 2016.

About closed triple therapy
The closed triple therapy is a combination of three molecules: fluticasone furoate (FF), an inhaled corticosteroid (ICS), umeclidinium (UMEC), an anti-cholinergic, also known as a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA) delivered once-daily in GSK’s Ellipta® dry powder inhaler.

About the ongoing clinical programme in COPD
The ongoing clinical programme in patients with COPD comprises two studies investigating the effectiveness and safety of closed triple therapy compared to existing COPD treatments.

  • The FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) study, which began in 2015 and is expected to read out later in 2016 to support EU filing, is assessing whether the closed triple therapy can improve lung function and health-related quality of life compared with Symbicort® (budesonide/formoterol), a twice-daily ICS/LABA combination delivered via the Turbohaler® inhaler.
  • The IMPACT (InforMing the PAthway of COPD Treatment) study, which began in 2014 and is expected to read out in 2017, is investigating whether FF/UMEC/VI can reduce the rate of exacerbations compared with two, once-daily dual therapies from GSK’s existing portfolio: FF/VI, an ICS/LABA combination and UMEC/VI, a LAMA/LABA combination.

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

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Innoviva - Innoviva is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, if approved and commercialized, VI monotherapy, as well. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination therapy for COPD.

For more information, please visit Innoviva's website at www.inva.com

Innoviva, Inc. enquiries
Eric d’Esparbes
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