Skyepharma's new asthma drug `Flutiform, accepted for FDA review

The US Food and Drugs Administration has accepted SkyePharma Plc's 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, the company said in a release.

If approved, Flutiform will be the first ever fixed-dose medication combining fluticasone, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta agonist (LABA), in the US, the release said.

Flutiform, which uses an environment-friendly aerosol propellant, hydrofluoroalkane (HFA), in a metered-dose inhaler, is aimed at the combination ICS/LABA inhaler market, the release said, adding that the market is forecast to generate approximately $10 billion worldwide by 2010.

Following the acceptance of the NDA for review, an amount of $2 million (£1.3 million) is due to SkyePharma from which the filing fee of $1.2 million (£0.8 million) will be deducted.

"We are pleased that the FDA has accepted the Flutiform NDA for review. This is a further step in the development of Flutiform. We believe that, if approved, Flutiform will provide physicians and asthma patients with an important additional treatment option to help manage this serious, chronic condition," said Dr Ken Cunningham, CEO of SkyePharma.

The NDA for Flutiform was submitted to the FDA in Q1 2009. ''The acceptance of the filing means the FDA has determined that the NDA is sufficiently complete to permit a substantive review. The regulatory review timeline for asthma treatments is typically longer than the standard 10-month Prescription Drug User Fee Act (PDUFA) timeline, the release noted.