FDA Panel Will Weigh Mixed Efficacy Data For GSK’s <em>Breo Ellipta</em> In COPD

FDA Panel Will Weigh Mixed Efficacy Data For GSK’s Breo Ellipta In COPD

15 Apr 2013

Agency says data supporting the relative contribution of the combination drug’s corticosteroid component, fluticasone, are “less robust” than data supporting the bronchodilatory effects of the long-acting beta-agonist component, vilanterol.

FDA’s Pulmonary-Allergy Drugs Advisory Committee will have to sort through inconsistent efficacy data during its April 17 review of GlaxoSmithKline PLC’s Breo Ellipta (fluticasone furoate/vilanterol inhalation powder) for both bronchodilation and reduction of exacerbations in patients with chronic obstructive pulmonary disease.

The committee will be asked to consider the efficacy data on each of Breo Ellipta’s individual components as well as...