Review of the European marketing authorisation application (MAA) for SkyePharma's asthma and chronic obstructive pulmonary disease (COPD) product Flutiform (fluticasone and formoterol) will take longer than originally anticipated, the company has said.
This is due to a lack of complete consensus on the drug by the Concerned Member States (CMS) within the timescale laid down by the European Union (EU)'s decentralised drug review procedure.
SkyePharma says its authorised distributor, Mundipharma, has been informed that the decentralised procedure for the review of Flutiform was unable to be completed at Day 210 with a consensus of the Reference Member State (RMS) and the 21 CMSs. While the UK - the RMS for Flutiform's review - and "almost all" of the CMSs were in agreement that the product was approvable, a complete consensus was not achieved by Day 2010, which fell on October 17 this year.
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," says SkyePharma, noting that the process should normally begin within 30 days.
The MAA for Flutiform was filed by Mundipharma in March 2010 and accepted for review in May of that year.
SkyePharma and Mundipharma say they are "confident in the efficacy and safety profile of Flutiform, which is supported by the clinical evidence." The MAA consisted of "a substantial package of data including the results of eight Phase I/II studies and nine Phase III sutdies conducted in a population of over 1,900 patients, they add.
- Reporting on the group’s first-half 2011 activities in August, SkyePharma had noted that "the approval and launch of Flutiform in Europe, anticipated for later this year, is pivotal to the value and longer-term cash-generative potential of the group."
With the drug's European approval, "the directors believe that the group would have good growth prospects, and further potential to exploit SkyePharma's proven drug delivery capabilities and technologies," said non-executive chairman Frank Condella.
The interim report also noted that Flutiform had now been licensed to Sanofi for Mexico, Central and South America, and that in Japan, good progress was continuing with two Phase III clinical trials. The group's licensee there, Kyorin Pharmaceutical Co Ltd, was continuing to plan to file the Japanese New Drug Application (NDA) for Flutiform during the fiscal year ending March 2013 and, subject to receiving approval, to launch the drug there during the fiscal year ending March 2015, it said.