The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended SkyePharma's flutiform (fluticasone propionate/formoterol fumarate) for European marketing approval.
Flutiform is a fixed-dose combination long-acting beta-agonist, formoterol fumarate and the prescribed corticosteroid, fluticasone propionate, designed for treating asthma patients.
Flutiform uses SkyePharma's patented SkyeDry formulation technology which improves the stabilisation of the labile formoterol molecule.
The positive opinion from the CHMP will now go through the standing committee procedure which, in the absence of any further issues, will be converted into a legally binding decision by the European Commission.
The marketing authorisation application (MAA) for flutiform included chemistry, manufacturing and control data together with the results of eight phase I/II studies and nine phase III trials.
SkyePharma chief executive officer Peter Grant said the positive opinion of the CHMP is an important step forward for the development of flutiform and the company looks forward to receiving the final decision from the EMA in due course.