GSK launches RELVAR® ELLIPTA®, a once-daily treatment for Asthma in Malaysia

Kuala Lumpur, 28th October 2015: Asthmatic patients can breathe a sigh of relief with the launch of Relvar® Ellipta®, a once daily treatment option by GlaxoSmithKline (GSK) and Theravance, Inc. Relvar® Ellipta® is the first combination inhaled corticosteroid/long acting beta2-agonist (ICS/LABA) that delivers 24 hour efficacy utilising the easy-to-use Ellipta® device.[1]

 

In Malaysia, 4.5% of adults have asthma.2 A large majority of asthma patients are under-treated and forced to miss work or school due to uncontrolled asthma attacks, which damps their quality of life.[2] Patients with poorly managed asthma make more emergency room visits and are hospitalised more often than patients with better control.[3] The Ministry of Health’s report in 2014 indicated that respiratory diseases accounts for 12.41% of hospitalisations in both government and private hospitals.[4]

 

Speaking at the launch, Dato’ Dr. Abdul Razak Bin Abdul Muttalif, Senior Consultant Chest Physician, Director of Institute Respiratory Medicine, Kuala Lumpur Malaysia said, “Research has shown us that despite patients getting treated for asthma, more than half of them do not have well-controlled asthma. Poor adherence to treatment contributes greatly to poor asthma management. One of the main reasons why there is low treatment adherence is because patients are uncomfortable to use the inhaler in public. If medication is not taken as prescribed, patients may have an increased risk of exacerbations (asthma attacks), which can, in extreme cases, be fatal.”

 

Relvar® Ellipta® is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2-agonist (LABA), vilanterol “VI” (FF/VI). It is administered once-daily1 using the Ellipta device, a new dry powder inhaler (DPI).[5] Relvar is indicated in asthma for patients aged 12 years and above, who are not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting β2-agonists1, and due to its long lasting formulation, it provides a continuous 24 hour efficacy that allows patients to use their inhaler once daily[6],[7],[8],[9] at a time convenient to the patient. Data demonstrates that efficacy is sustained regardless if the dosage is taken in the morning or evening.[10]

 

“Relvar® Ellipta® has been developed with patients in mind and we are proud to make it available to asthma patients in Malaysia whose lives have been continuously disrupted, because of poor management of the condition. Hence at GSK, we are committed to developing respiratory medicines that are shaped by the real needs of patients like the once-daily treatment for asthma. Our credo “do more, feel better and live longer” leads us to finding sustainable solutions to pressing health care challenges and addressing the unmet needs in today’s healthcare universe,” said Dr. Saikiran Leekha, Medical Affairs Director – Pharma & Vaccines, GSK Malaysia & Brunei

 

“There remains a need for simplified treatment and dosing regimens for asthma patients to improve adherence rates. The development of Relvar® Ellipta® that incorporates innovative design that patients find easy to use with well-established efficacy and safety is a much needed alternative treatment option for both patients and physicians,” concluded Dr. Saikiran Leekha.

 

 

The Burden of Asthma

Globally, asthma affects about 300 million people and the figure is expected to increase to 400 million by 2025.2 It creates a substantial burden on patients and family members, often causing them to make lifestyle adjustments and restricting their daily activities for a lifetime12. Despite medical advances, 53% of patients have poor control of their asthma3.

 

Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning.12

 

In Asia, a study showed that patients with poor control of asthma have a high risk of asthma attacks (62.2%), an increase in hospitalisation rate (37.8%) and loss of work days (37.9%).11 Subsequently, patients with low treatment adherence prefer oral tablets (31.2%) to inhalers and once-daily dosing (44.5%).11

 

The causes of asthma are not completely understood however key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.11 These include smoke and allergens like dust mites and pets.11

 

 

Respiratory Development Programmes

The GSK respiratory development portfolio includes LAMA/LABA (umeclidinium bromide (UMEC)/VI), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK’s investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.

 

RELVAR®, BREO™ and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.



[1] Relvar® Ellipta® 100/25 Malaysia Prescribing Information EUSPC May2014 MAL_1 August 2014 and Relvar® Ellipta® 200/25 Malaysia Prescribing Information EUSPC May2014 MAL_1 August 2014.

[2]Asthma: Breathe Easy Patient Guide, Lung Foundation Malaysia 2013. Available from: http://www.lfm.org.my/pdf/My-LUN-002_lowres.pdf [Last accessed Aug 2015]

[3] Demoly P, Annunziata K et al. Repeated cross-sectional survey of patient-reported asthma control in Europe in the past 5 years. European Respiratory Review. 2012;21(123):66-24

[4] Health Facts 2014, Ministry of Health Malaysia: Planning Division, Health Informatics Centre. Available from http://www.moh.gov.my/images/gallery/publications/HEALTH%20FACTS%202014.pdf [Last accessed: Aug 2015]

[5] Woepse M, Dale P et al. Qualitative assessment of a new twin-strip dry powder inhaler (DPI) for asthma and COPD. Presented at the American Thoracic Society Annual Congress, Philadelphia, PA, USA, 17-22 May 2013

[6] Bleecker ER, Lötvall J et al. Efficacy of fluticasone furoate (FF) as a monotherapy and in combination with vilanterol (VI) over 12 weeks in patients with persistent asthma. Presented at the European Respiratory Society Annual Congress 2012 Vienna, Austria, 1–5 September, 2012

[7] Salter M et al. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. American Journal of Physiology. 2007; 293: L660-L667

[8] Slack RJ et al. In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action. Journal of Pharmacology and Experimental Therapeutics. 2013; 344: 218-230

[9] Rossios C et al. Long-acting fluticasone furoate has a superior pharmacological profile to fluticasone propionate in human respiratory cells. European Journal of Pharmacology. 2011; 670: 244-251

[10] Kempsford R, The efficacy of inhaled fluticasone furoate (FF) and vilanterol (VI) administered in combination in asthma is comparable when administered in the morning or evening. Presented at the European Respiratory Society Annual Congress 2012 Vienna, Austria, 1–5 September 2012

11K.-C. Chiu, MD , W. Boonsawat, MD, PhD , S.-H. Cho, MD, PhD , Y. J. Cho, MD, PhD , J.-Y. Hsu, MD et al., Patients’ Beliefs And Behaviors Related To Treatment Adherence In Patients With Asthma Requiring Maintenance Treatment In Asia, Informa Healthcare: J Asthma, 2014; 51(6): 652–659

12 World Health Organization. Asthma factsheet [online] 2011. Available from: http://www.who.int/mediacentre/factsheets/fs307/en/index.html [Last accessed: June 2013]