Hong Kong Authority Approves flutiform(R) (fluticasone propionate/formoterol fumarate), a New Treatment for Asthma
HONG KONG, Nov. 8, 2013 /PRNewswire/ -- Mundipharma announced today that flutiform(R) (fluticasone propionate/formoterol fumarate), a new combination therapy for the maintenance treatment of asthma, is now available for use in Hong Kong. Approved by the Drug Office, Department of Health, flutiform(R) is the combination of fluticasone, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-agonist (LABA) therapy delivered via a single aerosol inhaler for the first time.
The new combination is indicated for the regular treatment of asthma in patients aged 12 years and over whose symptoms are either not adequately controlled with an ICS plus an as-needed short-acting beta2-agonist (SABA), or are already adequately controlled with an ICS plus LABA. (Ref. 1)
Asthma is a growing respiratory challenge globally and in Hong Kong
Asthma is estimated to affect 235 million people worldwide and is a major preventable cause of morbidity and mortality. (Ref. 2) In Hong Kong, more than 330,000 people suffered from asthma in 2011. (Ref. 3)
“Asthma still represents an important clinical challenge despite currently available treatments,” said Professor David Price, Centre of Academic Primary Care, University of Aberdeen, United Kingdom.
“According to the REALISE study, a recent survey among 8,000 asthma patients across Europe, 40% of the patients say they have had time off work at least once in the last year because of their asthma, and 70% of them have experienced other health problems related to asthma in the last year. In addition, 40% of the patients get short of breath when hurrying on level ground or walking up a slight hill, and 20% say asthma affects their sex life,” commented Prof Price.
The REALISE study also shows that less than half of those prescribed a preventative inhaler use it regularly as advised by their doctor. (Ref. 4) The survey sheds new light on why patients experience symptoms but do not recognise the need to take action to better control their condition. Notably, some of them find their inhaler a nuisance, difficult, or embarrassing to use, and others are not motivated to seek support and information from their doctor. (Ref. 4) The results suggest that understanding the underlying reasons for the sub-optimal management of asthma may help the asthma community find more effective ways to enhancing patient adherence to asthma therapy and to improving managing the condition.
“Our deep understanding of patient needs has driven us to actively pursue new and innovative treatments to help improve the health and well-being of patients with asthma - a chronic and debilitating condition that affects approximately 235 million people worldwide and 330,000 here in Hong Kong alone. The launch of flutiform(R) in Hong Kong is therefore timely and presents healthcare professionals with access to a treatment option for asthma patients which can markedly improve the quality of their lives,” said Mr. Raman Singh, Managing Director, Mundipharma Asia Pacific, Latin America, Middle East and North Africa.
A new treatment for asthma is now available in Hong Kong
Providing a fast symptom relief within one to three minutes of use, (Ref. 1) flutiform(R) is the first combination of fluticasone (a potent ICS) and formoterol (the fastest-acting LABA) in a single, modern aerosol inhaler. In phase III trials the fluticasone/formoterol combination has shown encouraging results in delivering efficacy and safety compared with its individual components administered alone or concurrently via two separate inhalers. (Ref. 5, 6) The combination has also demonstrated a comparable efficacy and safety profile with two main combinations in the market, salmeterol/fluticasone and budesonide/formoterol, (Ref. 6, 7) and is preferred by doctors and considered more effective than the two main combinations. (Ref. 8)
“flutiform(R) has a faster onset of action with comparable efficacy. It has a traditional inhaler style that patients are already familiar with, and no longer need to learn new techniques. The inhaler device also provides a dose counter for patients to keep track of amount of medicine intake, which in turn will help increase patient adherence and lead to better asthma management,” said Prof Price.
“We are passionately committed to helping patients live in a world where asthma is no longer a daily battle. With the new combination therapy, we hope it will address existing unmet needs in asthma and deliver clinical benefits that enable patients to live better and more fulfilled lives through the optimal control of their condition,” added Mr. Singh.
About asthma
Asthma is a chronic (long-term) inflammatory disorder of the airways which leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma is a serious public health issue affecting 235 million people worldwide. (Ref. 2) Patients with poorly managed asthma are at an increased risk of exacerbations, hospitalisation and death. Poorly managed asthma can also have a huge impact on a person’s quality of life and day-to-day activities.
About REALISE(TM)
The REALISE(TM) (REcognise Asthma and LInk to Symptoms and Experiences) survey, sponsored by Mundipharma International and developed in partnership with asthma experts, is a large pan-European survey of asthma patients which aimed to assess patient attitudes and behaviours towards their disease. The survey was conducted in 8,000 people with asthma aged 18-50 across 11 European countries between July and October 2012. In order to take part in the survey, respondents must have received at least two prescriptions for their asthma in the past two years and also had to be active on social media.
About flutiform(R)
flutiform(R) is a combination treatment for asthma, bringing together, for the first time, the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting beta2-agonist (LABA) formoterol fumarate in a single aerosol. flutiform(R) is indicated for adults and adolescents (aged =12 years) with asthma that is either not adequately controlled with an ICS plus an as-needed short-acting beta2-agonist, or is already adequately controlled with an ICS plus LABA. Mundipharma International Limited is licensed by Jagotec AG, a SkyePharma Group company, as the authorised distributor of the product for Europe and most other territories outside Japan and the Americas.
About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis.
For further information please visit: http://www.mundipharma.asia
References:
1. FLUTIFORM(R) pressurised inhalation PI (March 2013)
2. Asthma [webpage on the Internet]. Geneva: World Health
Organization; 2012. Available at: http://www.who.int/topics/asthma/en
3. Hong Kong Thoracic Society, Asthma in Hong Kong.
Available at: http://www.hkasthma.org.hk/en/about-asthma/asthma-hong-kong
4. Mundipharma International Limited data on file: REALISE -- European Asthma Patient Survey Results, 2012.
5. Pearlman DS, et al. Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone. Abstract presented at ERS, 24-28.09 2011 in Amsterdam, Netherlands.
6. Bodzenta-Lukaszyk A, et al, Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler: Respiratory Medicine. 2011; 105:5, 674-682.
7. Bodzenta-Lukaszyk A, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Abstract presented at ERS, 24-28.09 2011 in Amsterdam, Netherlands.
8. M Thomas, J Haughney, D Price. Physicians’ attitudes towards combination therapy with inhaled corticosteroids and long-acting beta2-agonists: an observational study in UK specialist care. J PragObs Res 2011; 2:25-31. (R): FLUTIFORM is the Registered Trademark of Jagotec AG used under licence by Mundipharma.
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