The European Medicines Agency (EMA) has approved Flutiform pMDI for use in the treatment of children with asthma aged five years and over.
Flutiform pMDI is a combination of fluticasone propionate and formoterol in a single pMDI, otherwise known as a press-and-breathe aerosol inhaler.
Flutiform has been available in the UK for the treatment of asthma in adults and adolescents 12 or above since 2012, and has a tolerability profile supported by extensive clinical evidence and real-world use in these age groups, according to the firm.
Extending the age group to five and above provides children of this age group with new maintenance treatment options where the use of an ICS/LABA combination is appropriate.
The decision was based on efficacy and safety data from two 12-week paediatric studies, which demonstrated that the treatment administered as two puffs of 50/5 μg dose twice daily was non-inferior on lung function endpoints to the currently established combination therapy - fluticasone propionate/salmeterol - and had a similar tolerability profile.
Also, during a 24-week extension phase of one of the studies, lung function improvements were successfully sustained.
"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 of Peterhead Medical Practice, Aberdeenshire.
"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," said Paul Schofield, medical director at Napp. "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.”
Asthma is the most common chronic disease in childhood and is a major health burden in the UK with impacts including long-term consequences such as an increased risk of lifestyle-associated diseases and poorer school performance.