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GSK launches the first once-daily single inhaler triple therapy for COPD, Trelegy▼Ellipta, in Ireland

01.11.2018

   

GlaxoSmithKline (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) are pleased to announce the launch of Trelegy▼ Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), the first once-daily single inhaler triple therapy for chronic obstructive pulmonary disease (COPD), in Ireland. Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.

Trelegy Ellipta is a combination of three components: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily via GSK’s Ellipta dry powder inhaler. The approved dose is FF/UMEC/VI 92/55/22 mcg once-daily. 1

Dr Robert Rutherford, Consultant in Respiratory Medicine, University Hospital Galway, said: “COPD is one of the most common respiratory conditions in Ireland. The biggest threats to disease progression are continuing to smoke and getting repeated exacerbations where patients’ symptoms suddenly worsen often as a result of infection. Inhaled long-acting beta-2-agonists, anti-muscarinic agents and inhaled corticosteroids all have been proven to reduce the risk of exacerbations. These three drugs have now been combined into one inhaler in the Trelegy Ellipta device and this is an important addition to the medications used to treat the more severe COPD patient.”

Trelegy Ellipta is supported by data from the FF/UMEC/VI development programme, as well as data from studies with FF, UMEC and VI either alone or in combination. 23In the landmark IMPACT study, published in the New England Journal of Medicine in April 2018, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’ 92/55/22mcg) achieved superiority versus Relvar Ellipta (FF/VI) on the primary endpoint of reduction in the annual rate of on-treatment moderate/severe exacerbations (p<0.001) and a range of other clinically important outcomes, including lung function and health-related quality of life. 3Read more about Trelegy Ellipta at www.trelegy.ie .

The Summary of Product Characteristics is available at www.medicines.ie.

To see more on the Safety Information for Trelegy Ellipta in Ireland visit Click here
 

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References

  1. Trelegy Ellipta SMPC https://www.medicines.ie/medicines/trelegy-ellipta-34025/
  2. Lipson DA et al. Once-Daily Single Inhaler Triple Versus Dual Therapy in Patients with COPD. New England Journal of Medicine. 2018; 378: 1671-1680.
  3. Lipson DA et al. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Resp Crit Care Med. 2018.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971, medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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