Panel backs Anoro Ellipta for COPD

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 11-2 that efficacy and safety data for Anoro Ellipta umeclidinium bromide/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) support approval for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Anoro Ellipta -- a fixed-dose inhaled dry powder formulation of umeclidinium bromide, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA) -- has a Dec. 18 PDUFA date.

The panel also voted 13-0 that efficacy data support approval and 10-3 that safety data support approval. Some panel members expressed concern that inclusion criteria for the four Phase III efficacy trials of the product and 30% patient drop-out rate made it difficult to generalize the safety data to a broader patient population with severe COPD and cardiovascular disease comorbidities. ...