GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta

GlaxoSmithKlineGlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, 'FF/UMEC/VI') for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Approval of this sNDA means FF/UMEC/VI could be used by physicians to treat a wider population of patients with COPD who are at risk of an exacerbation and require triple therapy.

FF/UMEC/VI is the first treatment to provide a combination of three molecules in a single inhaler that only needs to be taken once a day. It contains an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, delivered once daily in GSK’s Ellipta dry powder inhaler, which is used across the entire new portfolio of inhaled COPD medicines.

Patrick Vallance, President, R&D, GSK said, "Data from GSK's landmark IMPACT study provide important information on the efficacy and safety of these molecules combined in a single inhaler and the benefit they can bring to appropriate patients when delivered as a triple combination therapy. We have moved swiftly to file these data with the FDA."

In the IMPACT study FF/UMEC/VI showed superiority to the dual combination therapies (FF/VI and UMEC/VI) on multiple endpoints, including exacerbation rates, lung function and health related quality of life. This builds on substantial evidence from across multiple clinical programmes that has demonstrated the benefit of the molecules in FF/UMEC/VI both alone and in combination, for the treatment of COPD.

FF/UMEC/VI was approved for use in the US on 18 September 2017 for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo (FF/VI) and require additional bronchodilation or who are receiving Breo and Incruse (UMEC). If approved, the sNDA would broaden this indication.

Michael Aguiar, CEO of Innoviva added: "Trelegy Ellipta adds to the portfolio of Ellipta inhaled therapies, which has been developed because patients have different treatment needs. We believe the IMPACT data will provide clarity to physicians on how to treat patients based on their symptoms and risk profile and that Trelegy Ellipta will play an important role in treating patients who remain symptomatic and at risk of an exacerbation despite current therapy."

About IMPACT

The regulatory submission is based on the positive results of the landmark 10,355-patient InforMing the PAthway of COPD Treatment (IMPACT) study. IMPACT evaluated the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) compared with FF/VI and UMEC/VI, two once-daily dual COPD therapies from GSK's existing portfolio. Headline results were announced earlier this year and full data will be presented in peer-reviewed publications and future scientific meetings.

Further regulatory submissions with these data in other countries including the EU are expected in 2018.

About COPD

COPD is a progressive lung disease that is thought to affect around 384 million people worldwide.(1)

For people living with COPD, the inability to breathe normally can consume their daily lives and make simple activities, like walking up stairs, an everyday struggle. Patients with COPD suffer from symptoms of breathlessness and many have a significant risk of exacerbations, managing these aspects of the disease drives physician treatment choice.

Long-term exposure to inhaled irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.(2)

Every person with COPD is different, with different needs, different challenges and different goals. Understanding this and providing support to help meet these needs is the foundation of GSK's work.

About Trelegy Ellipta (FF/UMEC/VI)

FF/UMEC/VI is the first single inhaler triple therapy approved in the US for the long-term, once-daily, maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. It is not indicated for relief of acute bronchospasm or the treatment of asthma.

FF/UMEC/VI contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, in a single inhaler, the Ellipta, with which fewer patients make critical errors compared to other commonly used inhalers.

GSK's commitment to respiratory disease

GSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last four years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.

We remain at the cutting-edge of scientific research into respiratory medicine, working in collaboration with patients and the scientific community to offer innovative medicines aimed at helping to treat patients’ symptoms and reduce the risk of their disease worsening. While respiratory diseases are clinically distinct, there are important pathophysiological features that span them, and our ambition is to have the most comprehensive portfolio of medicines to address a diverse range of respiratory diseases. To achieve this, we are focusing on targeting the underlying disease-driving biological processes to develop medicines with applicability across multiple respiratory diseases. This approach requires extensive bioinformatics, data analytic capabilities, careful patient selection and stratification by phenotype in our clinical trials.

About GSK

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.

About 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®. 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 Trelegy Ellipta for COPD.

1. Global Initiative for Chronic Obstructive Lung Disease Global Initiative for Chronic Obstructive Lung Disease. 2017. Pocket guide to COPD diagnosis, management, and prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
2. Diagnosis of COPD. World Health Organisation. Available at: http://www.who.int/respiratory/copd/diagnosis/en/

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