FDA Panel Recommends Approval of Once-Daily COPD Treatment

Megan Brooks

April 17, 2013

The Pulmonary-Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) today recommended that the agency approve the combination of the corticosteroid fluticasone furoate and the long-acting beta-agonist vilanterol (FF/VI 100/25 μg once daily) dry powder inhaler (Breo Ellipta, GlaxoSmithKline) for chronic obstructive pulmonary disease (COPD).

The 13-member committee voted 9 to 4 that the efficacy and safety data provide "substantial evidence" to support approval of FF/VI 100/25 μg once daily for both the long-term maintenance treatment of airflow obstruction in COPD and the reduction of COPD exacerbations.

On a separate question, the committee voted 12 to 1 that the efficacy data provide evidence of a "clinically meaningful benefit" for FF/VI 100/25 μg once daily for the long-term maintenance treatment of airflow obstruction in COPD.

The vote was 8 to 5 that the efficacy data provide evidence of a clinically meaningful benefit of the drug for the reduction of COPD exacerbations. Those voting no on this question in general felt the data on COPD exacerbations were incomplete. "The evidence wasn't convincing," said panel member Peter Peduzzi, PhD, director, Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut.

The committee voted 10 to 3 that the safety of FF/VI 100/25 μg once daily in COPD has been adequately demonstrated for the proposed indications. The "no" voters in general voiced concerns about the risk for pneumonia and fractures seen in clinical trials and questioned the benefit–risk profile.

The FDA reviewers said the drug's safety profile appears "generally consistent" with other inhaled corticosteroid/long-acting beta agonist products approved for COPD but noted that an increase in pneumonias related to the dose of the FF component was observed. There also appeared to be an increased risk for fractures associated with use of the FF/VI combination over VI alone, they said. Other commonly observed adverse events included nasopharyngitis, upper respiratory tract infection, and oral candidiasis.

The FDA reviewers also felt that although the submitted data for the drug are "extensive, the data to support the benefit of FF/VI 100/25 over VI 25 is not entirely consistent." Committee member Dr. Peduzzi concluded that addition of FF provided "no added benefit over the VI component."

The FDA usually follows advisory committee recommendations, although it is not required to do so.