HSA approves new asthma indication for GSK's Trelegy Ellipta, the first once-daily single inhaler triple therapy approved for use in the treatment of both asthma and COPD in Singapore

SINGAPORE, April 5, 2024 /PRNewswire/ -- GSK Singapore announced that the Health Sciences Authority (HSA) has approved a new indication and a new strength for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI') for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a long-acting beta2-agonist (LABA) and an inhaled corticosteroid (ICS)^1. This adds to its current license for use in patients with chronic obstructive pulmonary disease (COPD) and makes Trelegy Ellipta the first once-daily single inhaler triple therapy approved for use in both asthma and COPD in Singapore.

This approval is based on the CAPTAIN study which has shown that in patients uncontrolled on ICS/LABA, the additional bronchodilation provided by Trelegy had demonstrated significant improvements in lung function compared with fluticasone furoate/vilanterol (FF/VI), in a single daily dose in an easy-to-use inhaler^2.

With the new approval, the available HSA-approved strength for either COPD or asthma is fluticasone furoate/umeclidinium/vilanterol 100/62.5/25mcg, and an additional dosage strength newly approved for asthma at fluticasone furoate/umeclidinium/vilanterol 200/62.5/25mcg.

Dr Stephanie Ambrose, Country Medical Director, GSK Singapore, said "There are over 200,000 adults living with asthma in Singapore^3,4. Among them roughly 25% are treated with ICS/LABA, and within this group, almost 60% – which amounts to about 35,000 adults – still experience partly-controlled or uncontrolled symptoms^5,6. With this latest approval, we are pleased to share that this group of adults will potentially benefit from Trelegy and can look forward to having better control over their symptoms."

In Singapore, the asthma mortality rate is three times higher than other developed countries such as New Zealand and the United States of America^7. This could be attributed to several factors such as low adherence rates to daily medications, poor patient perception of asthma control, misuse of reliever medication and unoptimized treatment.

Locally, it was reported that 25.6% of patients with severe asthma had an emergency hospital visit in the past year^8. This clinical burden translates into a substantial economic burden, both in terms of direct costs to the healthcare system and wider societal costs. In 2020, the economic burden of asthma in Singapore was estimated at SGD 1.74 billion (including both direct medical costs and productivity loss); 87% of this cost was attributed to patients with uncontrolled or partly-controlled asthma^9.

Dr Ambrose added "People with uncontrolled asthma tend to adapt their lives around their symptoms. This takes a toll on their mental wellbeing as they are often wary of activities that may cause a worsening of their symptoms and result in dreaded trips to the emergency room. As such, new treatment options to empower people living with asthma with more control are crucial in giving them a better quality of life."Asthma is a chronic lung disease that inflames and narrows the airways. Locally, it was reported that 25.6% of patients with severe asthma had an emergency hospital visit in the past year

*About Trelegy Ellipta (FF/UMEC/VI) *

FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK's Ellipta dry powder inhaler.

*About the CAPTAIN Study*

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) is a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication.

*About asthma*

Asthma is a chronic lung disease that inflames and narrows the airways and is characterised by symptoms such as shortness of breath, wheeze and cough, amongst others^10. Asthma affects 262 million people worldwide and despite medical advances, about half of children and youths, and a third of adults affected do not have full control over their symptoms^11.

*About GSK*

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

*References*

1. TRELEGY Ellipta Singapore Prescribing Information GDS12/IPI13a (SI).
2. Lee, LA, Bailes, Z, Barnes, N, et al. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. The Lancet Respiratory Medicine. 2021, 9(1): 69-84.
3. Wong, QYA, Lim, JJ, Ng, JY, et al. An updated prevalence of asthma, its phenotypes, and the identification of the potential asthma risk factors among young Chinese adults recruited in Singapore. World Allergy Organ J. 2023;16(3):100757.
4. National Population and Talent Division, Strategy Group, Prime Minister's Office, Singapore Department of Statistics, Ministry of Home Affairs, Immigration & Checkpoints Authority, Ministry of Manpower. Population in Brief 2023. 2023. 28p.
5. Koh, MS, Lam, SSW, Xu, X, et al. Comparison of adult asthma receiving primary versus specialist healthcare in Singapore; Data from SingHealth-Duke-NUS-GSK COPD and Asthma Real World Evidence (SDG-CARE) Asthma Registry. Abstract AO24-6. Asian Pacific Society of Respirology. 2023.
6. Koh, MS, Xu, X, Lam, SSW, et al. Evaluation of risk factors for poor asthma outcomes based on SingHealth- Duke-NUS- GSK COPD and Asthma Real World Evidence (SDG-CARE) Asthma Registry. Abstract AP09-375. Asian Pacific Society of Respirology. 2023.
7. Koh, MS, Yii, A, Ong, YY. Asthma in Singapore: Past, Present and Future. Annals Academy of Medicine. 2017; 46 (3): 81-83.
8. Lim, GN; Allen, JC; Tiew, PY et al. Healthcare utilization and health-related quality of life of severe asthma patients in Singapore. J Asthma. 2023;60(5):969-980.
9. Finkelstein, EA; Lau, E; Doble, B et al. Economic burden of asthma in Singapore. BMJ Open Respir Res. 2021;8(1).
10. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2023. Updated July 2023. Available from: www.ginasthma.org 
11. The Global Asthma Report. Int J Tuberc Lung Dis 2022; 26:S1-S102.