SkyePharma's inhaler takes step toward EMA approval

After years of delay and rejection, SkyePharma ($SKP.L) is finally getting some good news on Flutiform. An EMA committee has recommended approval for the combination drug-tech asthma therapy. This development likely amounts to a rubber stamp for approval around the EU, Reuters notes.

Flutiform's approval recommendation will be up for a legally binding vote from the European Commission in two or three months, SkyePharma said in a release. The company sees the development as a step in the right direction for the oft-delayed treatment. "This is a strong endorsement of our capabilities in developing innovative and complex respiratory products like Flutiform," CEO Peter Grant said in a statement. "It is also good news that we are now on track for a new treatment option to be available for many patients suffering from asthma across Europe."

Flutiform uses SkyeDry, SkyePharma's metered-dose inhaler tech, to deliver a combination of two drugs: the beta-agonist formoterol fumarate and the corticosteroid fluticasone propionate. SkyePharma aims to boost prescription adherence with the treatment, which features a counter on the inhaler that tracks how many sprays are left. It also combines drugs that are generally packaged separately.

But the path to adoption has been rocky for Flutiform. In 2010, the FDA rejected the combo treatment, leading Abbott Labs ($ABT) to dissolve its pact with SkyePharma for U.S. development. Its prospects in Europe seemed to dim at the end of last year, as SkyePharma failed to get unanimous approval from EU member states, leading the EMA to put off its ruling on the treatment.

But the latest recommendation seems to point toward brighter days for the British company. At least that's what investors seem to think: SkyePharma's share prices were 79% higher following Friday's announcement, according to Reuters​.

- read SkyePharma's release
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