UK drugmaker SkyePharma has reached agreement with US regulators as to the path it needs to take in order to prepare for a filing of its lead product Flutiform for asthma.
This represents good news for the firm which saw its shares stutter last month when the US Food and Drug Administration said that it wanted more information on Flutiform (fluticasone and formoterol). Now SkyePharma says that talks with the agency have led to an agreement on “an approach for the additional clinical work required” for the drug which will include a further study to provide more efficacy data.
The London-headquartered group added that discussions with the FDA are ongoing in relation to the design of the study and will be finalised after submission of supporting chemistry, manufacturing and controls data. All of this means that the anticipated date for filing of the Flutiform New Drug Application remains the second half of 2008 and the additional work will cost in the order of £3-£5 million. SkyePharma had originally hoped to submit the NDA in the first quarter of next year.
Despite the various setbacks, SkyePharma’s US partner on Flutiform, Abbott Laboratories, has not wavered in backing the development programme and both firms feel that the combination drug has the potential to become a blockbuster and challenge AstraZeneca's Symbicort (budesonide and formoterol) and Advair/Seretide (salmeterol and fluticasone) from GlaxoSmithKline.