Flutiform K-Haler (fluticasone plus formoterol) filed in UK for adults and adolescents with asthma- Mundipharma

Mundipharma has submitted a file to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) seeking a licence for its new product Flutiform K-Haler. The indication sought is for the treatment of asthma in adults and adolescents where the use of a combination product (ICS and LABA) is appropriate. The file will be reviewed through the decentralised procedure (DCP), one of the routes to obtain marketing authorisation for medicines in Europe.

The flutiform K-Haler contains the same combination of fluticasone propionate and formoterol fumarate as Mundipharma's existing asthma maintenance combination treatment, flutiform pMDI. The efficacy and safety of flutiform is supported by extensive clinical evidence. flutiform now has real-world use for up to three years across Europe and Asia-Pacific regions.