According to Mundipharma, the Flutiform fluticasone propionate/formoterol fumarate k-haler breath-activated MDI has received marketing approval through the European decentralized procedure for the treatment of asthma in patients 12 and older. The company had submitted the MAA in March 2016.
Flutiform k-haler delivers the same dosages as the existing Flutiform MDI, which was approved in Europe through the decentralized procedure in 2012.
Mundipharma Head of insights Jonathan Marshall commented, “Mundipharma has listened to patients and doctors to understand the day-to-day challenges of managing asthma. Our drug delivery expertise and approach to provide a range of patient focused solutions is aimed at helping to improve outcomes and enable people with respiratory diseases to breathe bette. This positive outcome is an important step in the regulatory process. We can now begin to apply for national approvals and reimbursement in the European countries covered by this procedure.”
Read the Mundipharma press release.