European decentralised procedure (DCP) approval for flutiform k-haler to treat asthma. - Mundipharma.
The Mundipharma network of independent associated companies announced the positive outcome of the European Decentralised Procedure (DCP) for flutiform k-haler, a novel asthma treatment for adults and adolescents (aged 12 years and older) where the use of a combination product (inhaled corticosteroid [ICS] and long-acting ?2-agonist [LABA]) is appropriate.
The UK�s Medicines and Healthcare products Regulatory Agency (MHRA) acted as the Reference Member State for the DCP, which covers 18 countries across Europe.
The K-Haler is a novel pMDI (pressurised metered dose inhaler) device, which has a simple breath-activated mechanism, and has been designed to make it easier for patients to use correctly. Incorrect inhaler technique coupled with poor adherence to therapy are considered common causes of uncontrolled asthma.
Comment:The flutiform k-haler takes its name from a unique kinked valve which removes the need for coordination, with only gentle inhalation required to trigger the aerosol.
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