Mundipharma announced the European Decentralised Procedure (DCP) license variation application for flutiform, extending the indication to the treatment of asthmatic children, has closed with a positive opinion. flutiform is a combination of fluticasone propionate and formoterol in a single pressurized metered dose inhaler (pMDI), otherwise known as a press and breathe aerosol inhaler. It is now indicated at a dose of two puffs (actuations) 50/5 µg for regular twice-daily, maintenance treatment of asthma in children aged 5 to <12 years when a combination of an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) is appropriate.
flutiform has been available in Europe 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 for six years across Europe and Asia-Pacific regions in this age group.
“We are delighted that the combination aerosol flutiform has now been licensed for use in children aged 5 to <12 years in addition to the current indication for adolescents and adults,” said Catriona Cutting, Head of Regulatory Strategy, Mundipharma. “Asthma affects all aspects of children’s and their families’ lives and new treatment options for pediatric asthma are still very much needed.”
Asthma is the most common chronic disease in childhood and represents a major health burden. Despite the availability of several pediatric treatment options, uncontrolled asthma is still common in children and morbidity from the condition is a major health burden for patients, their families and society. Poorly controlled asthma in children is associated with time off school, exacerbations and days in hospital. Recent studies suggest that poor asthma control may have a greater impact on children than previously thought, including important long-term consequences such as an increased risk of lifestyle-associated diseases and poorer school performance.
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“The pediatric license indication for flutiform is part of Mundipharma’s commitment to provide new treatments to help improve the lives of people affected by asthma,” said Alberto Martinez, President and CEO, Mundipharma International. “The use of this combination is now well established in adults and adolescents, and we are delighted that following this positive opinion we will also be able to offer this combination for the treatment of pediatric patients.”
The license variation of flutiform for use in children was based on efficacy and safety data from two 12-week pediatric 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. The 24-week extension phase also showed that children receiving flutiform had growth rates and plasma cortisol levels within the normal ranges. A 28-day knemometry study further found that flutiform did not suppress lower leg growth rate compared with baseline.
flutiform is an easy-to-use inhaler, which can be used effectively with or without a spacer (use of a spacer is advised for children who may find coordination of actuation with inspiration difficult). The recommended dose of flutiform in children is two puffs (actuations) 50/5 µg twice daily (BID).