GlaxoSmithKline plc and Innoviva, Inc. 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.
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