SkyePharma PLC met US Food and Drug Administration (FDA) to discuss the previously announced potential review issues in respect of the New Drug Application (NDA) for its lead development product, Flutiform (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12 years of age and older.
As previously announced, in June 2009 the FDA gave preliminary notice of some potential review issues which it had identified in its preliminary evaluation of the NDA, which had been accepted for substantive review. As a result, the company announced that it appeared likely that some additional clinical work may be required to provide more data on dosing and that a meeting was being sought with the FDA with a view to agreeing how the potential review issues may be addressed.
A meeting has now been held with the FDA and it has been confirmed that additional clinical work will be required to provide more data on dosing. The Board believes that it is unlikely that Flutiform will, therefore, be approved in the US before the second half of 2011. In the meantime the review of the NDA is continuing.
Under the current license agreement Abbott is responsible for paying for additional clinical or other trials required by the FDA, and is entitled to recoup such costs out of up to 25 per cent of any approval or post-approval milestones and royalties.
The potential review issues are not expected to have an impact upon the development of Flutiform for Europe or Japan, which remain on track.
Dr Ken Cunningham, chief executive officer, said, "We now have greater clarity from the FDA on its approach to our filing and we are working to address these issues as soon as possible. Flutiform™ remains on track in Europe and Japan, and we remain confident that, once approved and launched in its various markets, Flutiform will be a successful product for SkyePharma in terms of both revenues and cash flows."
Flutiform HFA-MDI is a fixed-dose combination of fluticasone and formoterol in a metered dose inhaler (MDI).