Asthma treatment approved in EU through decentralized procedure

UK-based Mundipharma has announced the positive outcome of the European Decentralised Procedure (DCP) for flutiform k-haler, a novel asthma treatment for adults and adolescents that contains the same combination of fluticasone propionate and formoterol fumarate (50/5μg and 125/5μg strengths) as the company’s existing asthma maintenance combination, flutiform pMDI (pressurised metered dose inhaler).

The k-haler is an aerosol device with a breath-triggered mechanism, activated with a low inspiratory force, which is designed to make it easier for patients to use correctly, including those who find other devices challenging to use.

Jonathan Marshall, head of medical insights at Mundipharma, said: “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.”