Flutiform review to take longer than expected, says SkyePharma

UK-based SkyePharma (LSE: SKP) revealed yesterday that the review of the European Marketing Authorization Application for Flutiform, a fixed-dose combination of fluticasone formoterol for the treatment of asthma, will take longer than originally anticipated due to lack of complete consensus by the concerned (European Union) member states (CMSs) within the timescale laid down by the decentralised review procedure.

It notes that European marketing partner privately held Swiss firm Mundipharma International has been informed that the decentralized procedure for the review of Flutiform was unable to be completed at Day 210 with a consensus of the reference member state and the 21 CMSs. The UK (the reference member state for the review of Flutiform) and almost all of the CMSs were in agreement that the product was approvable but a complete consensus was not achieved by Day 210, which was October 17, 2011.

The procedure has now moved into a referral process during which the Member States involved will use their best endeavours to achieve a consensus on the final regulatory position of Flutiform within 60 days of the process commencing. The process should normally commence within 30 days.