It was good news for SkyePharma last week after the US Food and Drug Administration agreed to review the firm’s marketing application for the asthma drug Flutiform, triggering a $2 million milestone payment from partner Abbott Laboratories.
SkyePharma says that if its application is successful and Flutiform (fluticasone and formoterol) receives the green light it will be the first ever fixed-dose medication combining the inhaled corticosteroid fluticasone and the long-acting beta agonist formoterol to become available in the US.
And according to Ken Cunningham, the UK drug delivery specialist’s chief executive, the approval of Flutiform will “provide physicians and asthma patients with an important additional treatment option to help manage this serious, chronic condition”.
SkyePharma is certainly pinning much of its hopes for near-term growth on Flutiform, the approval and commercial success of which is “expected to be transformational for the group”, particularly as the combination ICS/LABA inhaler market looks set to hit $10 billion worldwide by next year.
The drug has, however, suffered a slight setback on this side of the Atlantic after a technical error delayed its filing with European regulators, due to the need to recruit additional patients need into the on-going high-dose strength study.
