- Provides children aged 5 years and over with a new maintenance treatment option where the use of an ICS/LABA combination is appropriate
- Approval given following six years of clinical evidenceand real-world use of flutiform® press-and-breathe pressurised metered dose inhaler pMDI in 50/5μg strength in adolescents (≥12 years old) and adults, demonstrating effectiveness and good tolerability– 
Cambridge, UK, [11, January] – The European Medicines Agency (EMA), has approved flutiform® pMDI 50/5 µg, regular twice-daily for the treatment of children with asthma aged 5 years and over.1 flutiform® pMDI is a combination of fluticasone propionate and formoterol in a single pMDI, otherwise known as a press-and-breathe aerosol inhaler.4 This updated licence provides healthcare professionals with an additional option to help manage asthma in children.
flutiform® pMDI has been available in the UK for the treatment of asthma in adults and adolescents (≥12 years old) since 2012 and has a tolerability profile supported by extensive clinical evidence and real-world use in this age group.1
This new paediatric licence provides for a regular asthma maintenance treatment option, with a dose of two puffs (actuations) 50/5 µg twice-daily, in children aged 5 years and over, when a combination of an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) is appropriate.1
“I am delighted to learn that flutiform® pMDI is now licensed for children. The combination of fluticasone and formoterol in a device that can be used with a spacer will be a valuable addition to our options for treating asthma in children and will bring our paediatric pathway in line with what we recommend for adults,” said Dr Iain Small, Peterhead Medical Practice, Aberdeenshire.
Asthma is the most common chronic disease in childhood and is a major health burden in the UK. Recent studies suggest poor asthma control may have a greater impact on children than previously thought, including long-term consequences such as an increased risk of lifestyle-associated diseases and poorer school performance. When poorly controlled, it is associated with time off school and days in hospital.7 This is despite the availability of several paediatric treatment options.
Paul Schofield, Medical Director at Napp Pharmaceuticals Ltd commented, “extending Napp’s respiratory offering with the new paediatric licence for flutiform® pMDI demonstrates our commitment to this disease area; helping meet the challenges faced by the NHS in managing asthma and its impact on the lives of children and families. Despite the number of combination inhalers available, the majority are not available to treat the youngest patients, and we are proud to provide another treatment option in an area of medicine where there is still significant need.”
The licence variation of flutiform® pMDI for use in children was based on efficacy and safety data from two 12-week paediatric studies, which demonstrated that the treatment administered as two puffs (actuations) of 50/5 μg dose b.i.d., was non-inferior on lung function endpoints to the established combination therapy, fluticasone propionate/salmeterol, and had a similar tolerability profile., In addition, during a 24-week extension phase of one of the studies, lung function improvements compared with baseline were sustained.9
– Ends –
Notes to editors:
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a UK pharmaceutical company based in the heart of the Cambridge science community, and part of a worldwide network of independent associated companies across 48 countries. Napp has grown up with the NHS, providing innovative medicines to patients in the UK since the 1920s. Napp is committed to improving patient outcomes and ensuring the sustainability of healthcare. At Napp, we are proud of our heritage, which began in the treatment of chronic pain and has expanded into respiratory medicine, diabetes, oncology and inflammatory disorders.
For more information, please visit: www.napp.co.uk
About flutiform® pMDI
In the UK, flutiform® pMDI is licenced for regular twice-daily maintenance treatment of asthma when use of a combination product (an ICS and a LABA) is appropriate.1 flutiform® pMDI is licenced in 50/5μg strength for patients aged 5 years and above, 125/5μg strength for patients over 12 years, and in 250/10μg strength for patients over 18 years.1
Asthma is a chronic inflammatory disorder of the airways which leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing. 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.11
For further information please contact:
Head of Communications, Napp Pharmaceuticals Ltd
Tel: +44 (0)1223 424 444
® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence.
 EMC. flutiform 50 microgram/5 microgram per actuation pressurised inhalation, suspension. Available at: https://www.medicines.org.uk/emc/product/4277/smpc. Last accessed: January 2019.
 Bodzenta-Lukaszyk A, R Buhl, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Eur Respir J. 2011a;38:153s
 Bodzenta-Lukaszyk A, Dymek A et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med J. 2011;11:28
 Bodzenta-Lukaszyk A, Pulka et al. Efficacy and safety of fluticasone and formoterol in a single pressurized meter dose inhaler. Respir Med J. 2011;105(5):674-82
 Backer V, et al. Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management. Ther Adv Respir Dis. 2018, Vol. 12: 1–16
 Pedersen S. 2015. Asthma control in children: Is it important and can we measure it? Available at: https://www.sciencedirect.com/science/article/pii/S1526054215000809. Last accessed: January 2019.
 National Institute for Health and Care Excellence. 2017. Asthma: diagnosis, monitoring and
chronic asthma management. Available at: https://www.nice.org.uk/guidance/ng80/resources/asthma-diagnosis-monitoring-and-chronic-asthma-management-pdf-1837687975621. Last accessed: January 2019.
 Emeryk A, et al. A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma. Ther Adv Respir Dis. 2016;10(4) 324–337.
 Ploszczuk A, Bosheva M, Spooner K, McIver T, Dissanayake S. Efficacy and safety of fluticasone propionate/formoterol in paediatric patients with asthma. Thorax 2014 12;69:A177.
UK/FLUT-18075 | January 2019