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
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