Important Safety Information for FF/UMEC/VI in the EU
Positive top-line results of the phase 3 FULFIL (Lung FUnction and quality of Li Fe assessment in COPD with closed tr Ip Le therapy) study which investigated once-daily single inhaler triple therapy compared to twice-daily budesonide/formoterol were announced in June 2016 and published in 2017 (Lipson DA et al. The European Marketing Authorisation Application for Trelegy Ellipta is supported by 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. Understanding this and providing support to help meet these needs is the foundation of GSK’s work.Ībout the once-daily single inhaler triple therapy clinical programme in COPD supporting the European Marketing Authorisation Application 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. The proposed trade name ‘Trelegy Ellipta’ is subject to regulatory approval.ĬOPD is a common but serious lung disease that is thought to affect around 384 million people worldwide. FF/UMEC/VI is an investigational medicine not yet approved for use as a single inhaler triple therapy anywhere in the world. Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the US, Australia and Canada. A final decision by the European Commission is anticipated by around the end of 2017. Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”Ī CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.
said, “This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation. Patrick Vallance, GSK’s President, R&D, said, “We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers.” The proposed strength is FF/UMEC/VI 100/62.5/25 mcg. It is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP. Trelegy Ellipta 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. The proposed brand name is Trelegy Ellipta. (NASDAQ: INVA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for 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 (for effects on symptom control see section 5.1). GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc.
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