CHMP recommends Flutiform (Skye Pharma/MundiPharma) for Asthma

The CHMP of the European Medicines Agency ("EMA") has issued a positive opinion recommending the granting of a marketing authorisation for Flutiform (fluticasone propionate/formoterol fumarate) from Skye Pharma. The decentralised procedure ("DCP")of the marketing authorisation application for Flutiform was referred to the CHMP for arbitration because a concerned member state did not agree with the positive benefit/risk assessment made by the reference member state, the United Kingdom, during the DCP. The positive opinion adopted by the CHMP will now go through the standing committee procedure which, in the absence of any further issues, will be converted into a legally binding decision by the European Commission, a process which, typically, takes 2 to 3 months. The standing committee decision would be binding in its entirety on all 21 concerned member states involved in the DCP, which includes the UK, Germany, France and Italy, and they would implement the decision through granting of national marketing authorisations or approvals. The Group's development, marketing and distribution partner, Mundipharma, aims to launch as soon as possible after national approvals are granted and reimbursement confirmed.