Important Safety Information for FF/UMEC/VI in the EU Regulatory applications for once-daily single inhaler triple therapy FF/UMEC/VI have been submitted and are undergoing assessment in a number of other countries. On 18 September 2017, Trelegy Ellipta was approved for use in the US for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (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.įull US prescribing information, including BOXED WARNING and Medication Guide are available at. The results of the phase 3 FULFIL (Lung FUnction and quality of Li Fe assessment in COPD with closed tr Ip Le therapy) study were published in 2017 (Lipson DA et al. The European Marketing Authorisation for FF/UMEC/VI is based on efficacy and safety data from the FF/UMEC/VI development programme, as well as data from studies with the components either alone, or in combination. About the Clinical Development Programme Supporting the European Marketing Authorisation Understanding this and providing support to help meet these needs is the foundation of GSK’s work. 2Įvery person with COPD is different, with different needs, different challenges and different goals. Most people who have COPD are at least 40 years old when symptoms begin. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Long-term exposure to inhaled irritants that damage the lungs and the airways are usually the cause of COPD. 1įor 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. About COPDĬOPD is a progressive lung disease that is thought to affect around 384 million people worldwide. Prior to this being posted online, a copy may be requested from one of the GSK Media or Investor Relations contacts listed in the “GSK Enquiries” section at the end of this document. The first European launch is expected to take place before the end of the year.įor the EU Summary of Product Characteristics please visit. Having all three major classes of combination medication (ICS/LABA, LAMA/LABA, and now single inhaler triple therapy) in the single Ellipta inhaler is an important advance in inhaled therapeutics.” said, “Knowing that appropriate COPD patients will require triple therapy, Trelegy Ellipta affords the convenience of administration of three classes of medicines in a single inhaler. We believe this is an important innovation in COPD management and look forward to making it available for appropriate patients with COPD.” Trelegy Ellipta is the first medicine to be approved in Europe that delivers three effective molecules in a once-daily single inhalation. A combination of different types of medicines can be required to achieve treatment goals. Its progressive nature means symptoms can worsen over time with many patients also experiencing frequent debilitating exacerbations. The licensed strength as delivered is FF/UMEC/VI 92/55/22 mcg.Įric Dube, Senior Vice President & Head, GSK Global Respiratory Franchise, said, “COPD is a serious lung disease that affects millions of people. It is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK’s Ellipta dry powder inhaler. Trelegy Ellipta is the first once-daily single inhaler triple therapy to be approved in Europe. (NASDAQ: INVA) today announced that the European Commission has granted marketing authorisation for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc.
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