It's likely that SkyePharma isn't having a "Happy New Year" just yet. That's because the British drug delivery company now stands to face an additional delay of between 6 and 9 months in the approval process for its Flutiform asthma therapy.
As Reuters and the U.K.'s The Telegraph reported just before the holidays, European countries involved in approving Flutiform couldn't reach a unanimous decision, so the European Medicines Agency must now issue a verdict through majority voting, The Telegraph notes. The decision won't come now until later this year.
A European marketing approval application has been filed since 2010, and SkyePharma and development partner Mundipharma had hoped to gain approval in the summer. But as of Oct. 17, the company was forced to acknowledge that European regulators couldn't meet their timeline. The FDA rejected Flutiform in the U.S., and Abbott Laboratories ($ABT) cut its ties with the product.
Flutiform is a metered-dose inhaler that combines a fixed dose of two drugs—the "fast-onset, long-acting" beta-agonist formoterol fumarate and the corticosteroid fluticasone propionate. The treatment, which uses a built-in counter to track remaining doses, is meant to help improve treatment outcomes by boosting compliance through combining drugs typically in separate inhalers, the company claims.
Flutiform will also compete with some of the biggest products in Big Pharma—GlaxoSmithKline's ($GSK) Advair and AstraZeneca's ($AZN) Symbicort, among others, Reuters notes. Sanofi ($SNY), however, is licensed to pursue marketing approval for Flutiform in Mexico, as well as in Central and South America, SkyePharma points out on its website.
SkyePharma hit with European delay on Flutiform app