Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has received a positive opinion. Flutiform has been approved in Europe for the treatment of asthma in patients 12 and older since 2012. The recommended pediatric dose is two 50/5 µg puffs twice a day.
The Flutiform k-haler breath activated inhaler was approved in Europe for ages 12 and up in October 2017 and was launched in the UK in September 2018. The pediatric indication is for the standard Flutiform MDI, and the company advises use of a spacer for children who have difficulty coordinating inspiration and actuation.
Mundipharma President and CEO Alberto Martinez commented, “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. 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.”
Head of Regulatory Strategy Catriona Cutting said, “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. Asthma affects all aspects of children’s and their families’ lives and new treatment options for pediatric asthma are still very much needed.”
Read the Mundipharma press release.
