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FDA Advisors Recommend Approval of Breo Ellipta (Fluticasone Furoate/Vilanterol) for COPD

Agency decision expected in May (Apr. 17)

According to recent reports, the FDA’s Pulmonary–Allergy Drugs Advisory Committee (PADAC) has recommended that the agency approve Breo Ellipta (fluticasone furoate and vilanterol dry powder inhaler; GlaxoSmithKline/Theravance) for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The committee voted 9 to 4 in favor of approval. The panel also voted 12 to 1 that the data submitted for Breo Ellipta provided “substantial evidence” of a clinically meaningful benefit in terms of keeping lung airways open. In addition, the panel ruled 10 to 3 that the product’s safety had been “adequately demonstrated.” Some committee members, however, were concerned about a possible risk of pneumonia during therapy.

Breo consists of fluticasone furoate, an anti-inflammatory corticosteroid, and vilanterol, a long-acting beta-agonist (LABA), which opens airways. The combination product is administrated via the palm-sized Ellipta inhaler device.

Because it is dosed once daily, Breo Ellipta has the potential to displace Advair (fluticasone and salmeterol; GlaxoSmithKline), which is administered twice daily.

The FDA is expected to make its approval decision by May 12, 2013. The agency is not obligated to follow the recommendations of its advisory committees, but it usually does so.

Sources: Reuters, April 17, 2013; and Wall Street Journal; April 17, 2013.

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